Participants 🔗
- George Hattub - Senior Regulatory Affairs Project Manager (Presenter)
- Sam’an Herman-Griffiths - Junior Software Engineer
- Reece Stevens - Director of Engineering
- Matt Hancock - Software Engineer
- Mary Vater - Director of Regulatory Affairs
- Jim Luker - Senior Regulatory affairs Project Manager
Key Points 🔗
- Evolution of FDA Regulations: The FDA originated in 1906, inspired by public outcry over unsafe practices. Medical device regulations began in 1976, evolving to address design flaws and public safety concerns.
- Common FDA Violations: Issues like misbranding, adulteration, obstruction of justice, and wire fraud are prevalent. The Park Doctrine holds executives liable for compliance failures, even without direct involvement.
- FDA Enforcement Structure: The agency operates at three levels: headquarters (policy and reviews), investigators (on-site inspections), and special agents (serious cases involving law enforcement).
- Recalls and Case Studies: Recalls are classified into three levels based on risk. A case study highlighted ethical dilemmas in addressing issues with lead-testing devices and the financial and legal consequences of non-compliance.
- Key Lessons and Professional Pathways: Strategic thinking, ethical decision-making, and learning from mistakes are vital. Working as a consultant or within the FDA offers rewarding career opportunities in ensuring public safety and compliance.
Transcript 🔗
Introduction and Agenda 🔗
George Hattub: Today's agenda will focus on discussing medical device recalls.
The History of FDA and its Legal Framework 🔗
George Hattub: We’ll review the regulations surrounding recall types, analyze a software recall case study, and wrap up with takeaways and practical advice. And like Mary said, anyone that has any questions, please feel free to stop me and I will answer. So, we have the FDA that this is our livelihood, we deal with them, they're our customer. And the FDA came about in 1906 and it came about as a result of a experts to say that was called The Jungle. It described the horrible meatpacking conditions in Chicago at the time and how basically the American public was being poisoned with some pretty nasty stuff. And the people that came to America at the time, they were exploited. And so the person that wrote the book, The Jungle, wanted to appeal to better social conditions. Basically, what resulted was Food, Drug and Cosmetic Act because people became aware of how their food, contained less than savory things in it. And so the FDA Food, Drug, and Cosmetic Act that we use today was establish in 1906 by Theodore Roosevelt and the fundamentals to the act to act as a law. But basically, when people get in trouble with the FDA, it's pretty simple as far as what you can get in trouble for, you can get in trouble for it's called misbranding, adulteration, obstruction of justice, making a false statement, wire fraud, conspiracy.
Common FDA Violations: Misbranding, Adulteration, and More 🔗
George Hattub: And then I'll go into the Park Doctrine. But what basically what Misbranding is it's a misdemeanor. And for example, if you put your product on the market without a 510(k) that's misbranded, you think it would be higher, you know, a felony, but it isn't. Now the related crimes related that to that misdemeanor could be a felony. But that's the legal concept in misbranding goes under labeling. In other words, the claims you make and this was beginning with food in the beginning, eventually we'll get to drugs. Adulteration is an old fashioned term. Okay. But what that means is that product isn't made to what it's supposed to be made to. So, at the time when The Jungle was written, the only word to describe the food was it was adulterated. And so that legal term carries on to today. So, for example, if you don't make your product according to a procedure and you release it, it's considered to be adulterated, even though you might say, well, you know, adulteration only pertains to food and physical things, but that's the law that's been in effect since 1906. Now the ways in which you get in trouble, okay, those are the two legal concepts that adulteration of a food drug or medical device is a felony and misbranding once again is a misdemeanor.
But when the FDA conducts an investigation, okay, obstruction of justice can occur. And people don't intend for this to happen. But if you in any way mislead the FDA or send them down a false trail when there's an investigation that's considered to be obstruction of justice, and then any time you make a false statement to the FDA, that's also a crime. And so, and then the other crime is wire fraud. So wire fraud used to be just through the mail, before the internet or the telephone. Now, it involves everything electronically. And so if you make a false statement through the internet, that's considered to be a bold statement and wire fraud, in addition, because you're crossing state lines and then lastly there's conspiracy. And so usually what happens when a crime occurs okay, is that other people are involved. It could be your boss. It could be a fellow at work or whatever. And once two or more people are aware of an issue in and let's say they tried to cover it up, then conspiracy comes in to the possible crimes.
The Park Doctrine and Corporate Liability 🔗
George Hattub: Then there's Pack doctrine. And this was a supreme Court decision that was made in 1975. And the Supreme Court established that an executive of a company can't claim “I didn't know.” In other words, if you're a corporate entity in the company, like a CEO, someone with fiduciary responsibilities, what this doctrine says is that you're liable, you're liable for your employees. And that's very important with the FDA and the law. So once again, you have FDA, the it's Food and Drug Administration, but the law is the Food and Drug Cosmetic Act.
Evolution of FDA Regulations for Medical Devices 🔗
George Hattub: So next slide, the FDA medical devices. So Jim will probably appreciate this okay. 1976 was not too long ago. So believe it or not, before 1976 the FDA had no legal authority to regulate drugs. And that's, you know, we had put a person on the moon several years earlier. So it's pretty crazy to think that medical devices weren't regulated. And during the 70s, that's when there was a social awareness. That's where the EPA was established. The Environmental Protection Agency, OSHA and other regulatory bodies. And so with medical devices in the early 70s, a study was done. In that study, they believe that over 10,000 Americans would lose their lives each year because of defective medical devices. And the reason I have Hawaii Five-O over here, this is from 1968, this is the first season. And anybody that wants to learn medical devices, there's, a two part series and in the corner is a person operating a medical device in a courtroom.
FDA Enforcement Levels: Headquarters, Investigators, and Special Agents 🔗
George Hattub: Basically, it would they were floating the idea of why medical devices needed to be regulated in popular culture. And when you watch this episode, it's kind of corny, but I'm telling you, you watch it and it'll tell you why the FDA is involved with regulating medical devices. So for this presentation, what I want to describe to you, and this is my own definition, okay, there's three levels of the FDA in terms of enforcement basically. So there's level one and that's who we deal with. That's the FDA headquarters which is located in Maryland. And this is where headquarters is located, upper management, And when we send out 510K okay. Now it's electronically. This is where they were reviewed. And prior to the pandemic, they would be in this building. Now the FDA has a pretty, liberal remote policy. This is why sometimes will receive additional information, letters at like 9:00 at night because they have a flexible, flexible work schedule. So the people that we deal with FDA, scientific reviewers, and even though the FDA is a law enforcement agency, the people once again, that we're dealing with are very smart people like us, okay? And they're trying to do a good job and just their mission is to make sure that the devices are safe and effective. So their customer is the public and we're the public.
So then there's level two. If you've worked in the industry, where I've worked many years actually in locations that are registered with the FDA, the FDA has a legal authority to be able to enter your building. You cannot deny them and to inspect the medical device facilities. So when the law was created in 1976, there weren't many software control devices. So most of the law pertains to physical devices. And it's worded in that fashion. But for the sake of what we do when the FDA comes in, let's say it's a registered or office, and they produce a software controlled device that is, which what they'll inspect. So yeah, they're not going to check whether or not you have a rodent control procedure, which they would if you have a medical device company. But they will review the design history file. And what you're looking at is an actual FDA badge. And they carry that. They’re called investigators a lot of times people call them inspectors, but inspection is what the FDA does when they come to a medical device facility and the way they record their observation is on inspection report form.
When I first started my career, and I went to a seminar that was given by a former FDA investigator, now turned consultant, he said, think of it this way. So when the FDA comes to inspect you, they're not there to tell you, well, you have a great company. Good job. They're there to gather evidence to indict you. Now, they don't start off like that. But this is what you have to remind yourself that that compliance is not an option. It's the law. And if you're out of compliance and if the degree of out of compliance created a safety risk, it could cause problems down the road. If during an inspection, let's say you lie or mislead the investigator so that you don't get a warning letter or lose your job or whatever, you could possibly get in trouble with what I said before. Now the FDA there, they understand that, you know, we're all humans and, you know, we make mistakes. And whenever they judge a situation, they're looking for willful intent.
So once again, you know, they carry badges, they're investigators. Most of the time they're not problems. Usually when you look at when people get in trouble, which we'll go into in a little while, it's because something big is happened. So then there's level three and that's the special agents. So the FDA, created this section in the early 90s, and it had to do with, you know, the chance of violence because, you know, they're not only dealing with devices, they're dealing with foods, drugs and so if people are, you know, doing something permanently nefarious, it could get dangerous.
And so the FDA has special agents. So if you look at the LinkedIn profiles, some of these special agents or, you know, some of them don't have it, but I just know from personal experience is that they’re former FBI agents, IRS agents, you know, they could be even part of the TSA, but they're involved in law enforcement. So when they're called in, they're given a lot of power and they actually wear firearms. And so if you're ever involved with something like that, it's a pretty serious issue. So, I asked you before joining this meeting to visit the FDA website for recalls. And then put in the term software related. And if you notice, just this year there's been 146 software recalls.
Understanding FDA Recall Classes 🔗
George Hattub: Now some of them are repetitious because when you have a recall situation, it can get pretty extensive in other words, a company may have a recall on one product, and then they'll discover that they have the same product, same issue on a related product. And this will cause, you know, like the domino effect, but you can learn a lot from this website, okay. Because you can get a sense of what companies report as problems and what companies don't report as problems. So for example, when I worked for Company name, because we were a fortune 50 company, basically any time somebody reported an issue, let's say with the implant, they would submit a medical device safety report. And their conclusion was it wasn't our fault, it had to do with this or that. So if you visit the more database and you google, let’s say Company name, you might see a thousand, medical device reports and you'd say, oh, they're, you know, they're making a bad product. And it's not that they tend to over report. And the same thing can happen here with recalls in a different sense where companies can underreport.
So you might visit this website and you'll see, you know, what a company like Philips gets involved in one of the largest recalls as we speak, or a kind of a non software control product, the CPAP machine. But it got pretty serious. So they tend to report more issues because they're under, you know, the eyes of the FDA right now where some companies they may not report an issue. This is what you can glean from that. So there's three levels of recalls is class one, class two and class three. And unlike medical devices, where class one is pretty safe well understood devices, class one recall is the types of recalls that will be on CNN or, you know, national news. You'll say, don't eat this. These cantaloupes are bad, or right now it's cucumbers. And same thing with medical devices, if you have a CPAP machine made by Philips, stop using it now. You know, you may inhale and choke to death on the plastic. So a class one recall means a death has occurred or it could occur. And there are regulations of how that recall has to be communicated to the public.
Class two recalls of the majority recalls. And those are the ones where the FDA will say there's a reasonable chance of a safety issue happening. So most recalls, when you reach that level, you may think it's minor. The FDA will always consider, extrapolate it to be the highest, you know, this could be a safety issue. So these are the majority of recalls a class two that's a serious and like, you know, medical devices, class two devices comprised a majority of medical device clearances. And then there's finally class three. And class three is a seldom use recall. But that's if you make a minor mistake. In other words, if you printed, you know, you get a spelling error in your labeling or something that you know, it's not going to be a safety issue, but it's going to force you to do a recall to recover the product, okay?
Because once the product is outside of your jurisdiction, to get it back, it's a recall. You know, companies will use a rationale call, you can do a market withdrawal or whatever that means. If your physical product is in the warehouse and you discover a problem that hasn't been released to the public, then you might not have to let the FDA know because you're still in control. That's how some companies will avoid having a recall. The gray area occurs with software because, as we know, software is distributed through, you know, internet, the cloud. And if we discover a problem, we can correct it pretty quickly. But if you follow the letter of the law, that could be interpreted as a recall. Now, the good thing is that we don't own the software that we're producing, I don't think in most cases.
So it's up to the company that's the manufacturer who's distributing the product to make this decision. But when you have a problem, you have to tell the FDA and the FDA is going to find out sooner or later. And I just know that from personal experience on other things.
Key Takeaways on Recalls and their Legal Implications 🔗
George Hattub: So having a recall is not a crime, it's a remedy. The law is closed loop. And so it's a formal way of removing or correcting a problem, it protects the public, and there's a follow up and closure to it. So if you ever been involved with a physical recall sometimes they can last a while because, you know, it could be a function, the expiration date of the product.
You know, you have to have an effectiveness check on the recall. So in other words, they allow you to say we've recovered 75% of the product. And, you know, and we can't find the others. And therefore we think it should be closed and the FDA will stay fine, they have a recall coordinator in each district in the United States and they will they'll come in on the follow up and conduct an investigation.
Case Study: Lead Testing Devices and FDA Violations 🔗
George Hattub: But possibly if they find evidence to that effect, and that's usually where the crime may occur, will be revealed. It's when you have the closure or the, you know, follow up to the recall. So now we're going to talk about the case study. So right now up in Massachusetts, this is actually occurring and basically, there was a company that, in around 2007, received FDA 510(k) clearance for a device. Before I tell you, we're going to talk about the device which is lead tested. So why did I select this. First of all it's a software control medical device, there was a 510(k) case submission involved, there was an FDA request for additional information, there was a letter to file. The company was in the biggest deal ever. There was a consultant. And then there were recalls. Then there were the alleged crimes which I say were committed by good people. People that, you know, thought of themselves as good, as ethical, probably could never imagine themselves being in a situation. So what you're looking at right now is a software controlled device. The one on the left that was cleared around 2007. And the company which is located in Massachusetts, this is all on the internet, they had to patent to this technology and I think they virtually had a monopoly due to the patent a 510(k) clearance. But the product was cleared in 2007.
Company was very successful selling the product and the company's growing. And then, you know, as things manifest themselves in business, there was the product on the right, which is called the Ultra. And this is the new and improved version. And so when they do these Lead tests, they want to do it quickly, I think the turnaround time is like a day or so. So to test for lead is very important because if you have lead poisoning that's not a good thing. And you may have lead poisoning, you may not even realize it. So once again, they built up a really big market. They were very, very successful. And they developed the lead cure ultra. So in 2013 they submitted a 510(k). Just like how we know from our experience, like just because you have a 510(k) and you want to submit another one for almost the same type of product, doesn't mean that it's going to fly through. There's different reviewers, the FDA is always changing. I usually tell people that the FDA of 2025 you'll be saying that in 2030 was easy. It never gets easier, is what I'm trying to say. Back in 2007, which, you know, that was in the peak of my career, we were saying, oh, the FDA's is ridiculous, too hard. And so my point is, in 2013, when they submitted this 510(k) for the new improved ultra device, which had certain features, the FDA reviewer had a pretty typical question, which resulted in like an AI letter, additional information letter. It required them to perform follow up test. So it was during this testing that they discovered, issue. And basically it was that the tests were repeatable. And with this particular model, it had a propensity to give low test results on Lead thoughts, in other words, saying, oh, you know, your lead level is this and, you know, it was really higher.
So they were somehow able to satisfy the FDA and provide results. But basically the testing was conducted under ideal conditions. So they received a 510(k) clearance. After they released a new and improved model, complaints started to come in because the issue they had was noticeable. What I mean by that is that when they were doing the investigation on the leadcare ultra, they kind of discovered that the leadcare II, which was their bread and butter product that had been around, you know, like seven years or whatever, kind of had the same problems.
So the complaint started coming in. They had to reply to the complaints. The complaints started coming in for the leadcare ultra at a higher rate. And I guess they hired a consultant. And so, you know, what do we do? And they didn't want to report it to the FDA. The consultant basically gave him an ultimatum and said, you know, if you don't report it, I will. Because now the consultants involved, on site and so it forced them to do what they were supposed to do, which was report the problems to the FDA. So you report it through, it's called medical device report, and so this is a common thing with the FDA.
They receive these things all the time. So a less sophisticated company might think, if I submit a report, that means the FDA is going to be, you know, knocking on my door, tomorrow. And that's not the case. If anything, the FDA could take them a while. It's on record that that you've submitted this report. And if you're doing everything that your quality system tells you to do, you know, you have to report it on your capper. Then you have to send a response to the client. And so it just leads to other things. But the fact of the matter is, the FDA is getting these reports. And when they eventually come around to investigate data, that's when they'll look at it. You remember the second badge I showed you. So like I told you, they knew they had an issue on the leadcare II. And the CEO and the COO were in the position of selling the company when this was all occurring. They were going to sell to a very big company. And basically they told the people, stop looking at the things, it is what it is, maybe in the ultra we can't do anything about it, but bread and butter product, the leadcare II, we need to figure out some way to handle. So that's when they wrote the letter of file. Basically they changed the labeling because they made the labeling so that it was less likely that you could get false reading. So the CEO and COO, they sold the company while this was happening, and they were writing emails to people saying, you know, don’t do this. They actually had it written that we need to have plausible deniability, things to that effect And they sold the company for $66 million, in which, let's see, the CEO's got $2 million, the COO got half a million, the RA director got nothing.
So after they sold the company, then they started submitting more reports to the FDA and around 2017, the FDA started connecting the dots. I don't know if other people were reporting I'm sure that was happening. But that's around, you know, so we're going back to 2014, and now it's three years later. And that's when the FDA started to investigate. So during that investigation, that's when they started getting the story as far as when did you know, they wanted a timeline. And you know the problem when you lie, you have to remember your lies. And then, everybody knows why you shouldn't. Bottom line is that the CEO and everybody left. The CEO went on to run another company and I think she was woman of the year. The COO went to another state not escaping or anything just moving on. And RA director, she went to another place. But all this paperwork remain. And then there was also the slight problem, they sold the company. And how does that work? Well it does. You don't get a mulligan with the FDA, the company that bought the company, even though they didn't do anything wrong, they basically had to settle with the FDA for $28 million. They had to plead to it, okay. And they had nothing to do with it. So you do the math where they say 66 million minus 28 million. So that's how much the company was sold for. So that's outcome number one. Outcome number two. And that's why, you know, I probably wouldn't put it on the website because, you know, these people are innocent until proven guilty and they've been charged. They went and you know, during the pandemic I guess the investigation slowed down.
But up here in the northeast, when and when this happened, this was headline news on the Boston Herald, the Boston Globe, they had their pictures, like these were evil people. You know, even though it's like, okay, let's try to understand the situation. Are they guilty of a crime. You know who is really the guilty ones? You know, the boss or the some the other person was told to do something. So I'll leave you with this is the lessons to be learned. Think strategically. And that's, you know, if you're going to be in this career profession, you always need to, you know, be a couple steps ahead of things. You know, whether we do a 510(k), you do an audit or whatever, but think strategically. And then what I try to not to do is to judge the mistakes of others. So in other words, you know, it's really simple to say, oh yeah, they're guilty. But when you're working in a company and things happen, you know, hindsight is 2020. And so I try not to judge the mistakes of others because you never know, you might be put in a situation that's out of your control. So learn from them. Then things may seem black and white like right now, but there's that gray zone. The ends don’t justify the means. Okay, so you know, if you're involved in this situation so well, you know, I'll lose my job and my house or whatever, you know, that doesn't cut it.
And then what I always recommend is be a consultant. It's a safe and great career path because, you know, as consultants, you get an insight into what goes on when you work for these companies. You know, when I was at Company name was great because, we had so many layers of bureaucracy, was virtually impossible to, you do a crime. And they also told us we'll be harder on you than, you know, the FDA. And that was a fact. But when you work for these small companies, you know, sometimes you know they're struggling for funds and things like that. And so I just took a consultant in the medical device industry is a safe and great career path or work for the FDA, the good people. And it's a noble profession. I admire what they do. And most of the people I've met at the FDA, they are not mean people, they're not vindictive people, they have the mission to protect the public. So that's all I have. So even though I had that little mess up in the beginning, it didn't set us too far behind.
I'll be happy to take any questions. If you guys want to know more, you can get the court case. It's on the internet, and it's really, you know, it's about 300 pages. I'll tell you step by step what went on. So any questions?
Jim Luker: That was great George!
George Hattub: You liked those 1976?
Jim Luker: Yeah. At first Rocky, it was meaningful to me. Most of these people were not even nearly thought of.
George Hattub: But I just find it amazing, you know, because, prior to that you could do whatever you wanted medical device wise, and I remember reading a paper from 1976 or 75, and this was in a company I worked with, they actually had it and you know, it was kind of like, oh, you know, it's the FDA, they're going to start regulating medical devices. And the FDA, in the beginning, they didn't have much teeth, okay. Because when the FDA first got the authority inspect medical devices, it was GMP. It wasn't QSR, it was GMP. Good manufacturing practices. And the law was written from the view that all quality problems happened because the American worker is lazy and they're making mistakes. What the FDA found and also the FDA had a obligation to inspect factories every two years. And so what the FDA found during inspections was that the people were trying to do good jobs. They weren't willfully making mistakes. It had to do with, you know, design flaws or your flaws in the system. And the FDA didn't have the authority to go into design controls and to go into other areas of the company management review. It wasn't till after we had some really disaster recalls in the 80s and 90s, which would, dealt with heart valves or angioplasty catheters, break into people's bodies. So, you know, the FDA received the authority to increase the regulation. In other words, that meant they could inspect design control. And then also, that's when it became mandatory to report your problems to the FDA because they'd have these exposures on TV or the front page in the New York Times, let's say, can you believe that this happened right under the nose of the FDA and an FDA would look really bad.
Differentiating Software Bugs from Recalls 🔗
George Hattub: People would say, well, we're spending money. How come we're not getting the results? And so what you're seeing now is the, you know, the results of all the things that have been learned. Yes, Mary.
Mary Vater: Thanks. Yeah. There's a couple of questions in the chat.
George Hattub: Oh, okay. Yeah. Can you read those for me.
Mary Vater: Yeah. So can you speak to what differentiates a normal software bug in the field from a software bug that would require a recall, and what's the process of making that decision?
George Hattub: Oh, that's a tough one. So the FDA requires every company to have a complaint procedure. So when you do a complaint procedure okay. It's a flowchart. And as you know, this flowchart can be interpreted in different ways. And so you might fix a software bug and the FDA could look later on and say, you know, that was a recall. I've been in those situations. I worked at a company once. I was told, you know, by the president of the company that you cannot tell the FDA this is a recall you can get you can get all the product out of the marketplace.
But if you inform the FDA that this is a recall, not only would I have been fired, but it wasn't going to happen. And at the time, you didn't have to report recalls to the FDA. So I had some wiggle room. But the FDA inspected us two years later, and I remember I was the only one in the conference room. When the FDA was going through all the complaint files, the FDA looked at me and said, this looks like a recall. And I couldn't say anything. All I had was all my spreadsheets to show. I got all the product out of the marketplace. We destroyed it. And communicated to everybody.
Basically the FDA, you know, they gave me a mulligan on it, I can't guarantee that'll happen to everybody. So I guess what I'm trying to say, to answer your question is that it's not up to us to make the decision. If there's a recall, it's usually up to the director of QARA for the company. And usually these types of decision are made with the consensus. That consensus could also involve a lawyer. So you know, if you read the letter of the law, you might be working on something that you would think this would meet the definition of recall. And what I would say to that is that, well, you know, fixing a problem isn't necessarily a bad thing.
Just like in the situation where, the president of the company said, you know, if you report to the FDA, I'm going to fire you, okay? And it's like, okay, if he fires me, I know this product that could cause a problem is going to hurt people. And I know how to get all the product. You gave me all the authority to get all the product out of the marketplace. So I don't know if that helps you, but usually companies will have a procedure. The problem with software is that's we expect bugs to be in software. So in other words, I think the FDA…we kind of have a lower bar with them. We can fix something really quick. And we could demonstrate that everybody get the patch. That's where all the cybersecurity stuff is coming up. But I'd say this is that if you fix a bug and it's to fix a potential safety issue that would be a recall. But it's not up to you to make that decision. You would simply report it to your supervisor and then they would make that decision. So I don't know if that helps you, but yeah.
Decision-making During FDA Investigations 🔗
Mary Vater: I think what it boils down to is that bug a likely safety risk. And if so, then that requires a health hazard evaluation and more investigation to evaluate the impact and see if it qualifies as a necessary recall in those cases.
George Hattub: But if your conscience is bothering you, another words, you have you have the law and the law sometimes is not totally ethical. It's in life and so I think that when you find yourself in those types of decisions which are situations, you have to ask yourself, I mean, like how Yujan has it, would you use this on your mother or whatever? That's usually how I look at things. And when I've, you know, walked away from something, you know, it's because I just can't live with this. You guys can do what you want to do. I'm going to report to the FDA and this is one of the reasons I'm a consultant. When I first started my career, I started out as an engineer. And that's all I wanted to do is people leave me alone. Just let me be an engineer. But unfortunately, that's not how the world works, you know? And so gradually I got pushed up and so what I found is that when you're in those high levels, you know, your director, QA, every day is possible. You know, problem. Whether someone wants to use something for off label use, you know, or if someone is like exaggerating the application of the law because it can work the other way around. And so at the end of the day, a company is in business to make a profit. And the laws don't recognize that. And so it's not a it's not an easy answer. And I'm sure you know, Jim probably could tell me stories or, or you know, you seen situations like that and you we don't need to go into it. But all I can tell you is that after about the third company I worked for, you know, I just saw a patent and I remember I said that was when I said, I'm going to be a consultant, you know, it's. And then, you know, there's been no regrets because I think it's a great career field. Any other questions?
Mary Vater: Yeah. There's actually quite a few, several questions. So the next one is can companies contest recalls. Have there ever been recalls that are reverted or overturned after a notice had already been made to the public? Or once you get that ball rolling.
FDA Mock Investigations and Preparing for Inspections 🔗
George Hattub: Once you get it, it takes off? Let's see, I've been involved in two official recalls. Personally and then, advising clients and the other one and once it happens, once you make that call, the saying goes a die is cast. So that's why, you know, a lot of times companies will bring in the lawyers too and, but you have to be careful there because if you go back to the presentation there's a story. I'm the one with the 1976. There was the Ford Pinto. And Jim knows about this. Ford Pinto was a great car, you know, was America's answer to foreign competition. The only problem is that the gas tank was so close to the trunk that you got a little rear end, right? It was a two door. So you want to read, if you want to know about recalls, like in automotive, check out the Ford Pinto because the company actually made a decision that was cheaper to pay off the wrongful death suits than it was to, you know, do a $20 fix on the car. And so, you know, we're not the only industry that, you know, has issues.
Mary Vater: Yeah.
George Hattub: Next question.
Mary Vater: Yeah. So what are some things that company can do to prepare for an FDA investigation or an audit to avoid the risk of being seen as non-compliant? So yeah, the ultimate solution is to have good procedures and follow them. But do companies specifically prepare for them like mock investigations or what.
George Hattub: Yeah. So I used to do these too. I do them overseas because I actually have an FDA badge and you can't have a badge in the United States because that's impersonating the FDA investigates a crime. But for theatrical purposes, you could. So I would get hired in companies would hire me to go in and to pretend I'm the FDA and pull no punches. And I would get paid a lot of money to do this, you know, have my flight, nice hotel. And they wanted a report on would they survive an FDA inspection. And sometimes after like I had one particular inspection, I did okay. And it was for sterilizers. It was for the table top autoclaves. I was doing the inspection and I discovered that the doors could blow off.
Okay, because these are under pressure and everybody in the company knew about it. And they fix the problem, but they didn't report to the FDA and the problem was sitting in the campus system, you know, and so during the inspection, I said, we have a problem here, you know, because I was hired to do a good inspection and the guy that hired me was based in the United States. He was upset with me because he said, what are you doing? You know, and I said, I was asked to inspect the place. And I found these problems. And you told me you had no complaints, and they had them over here. And I said, how could that be? Well, needless to say, you know, I finished my report. I let them know what the problem was.
Once again, the problem was fixed, but definitely should have been recalled so we could have gotten killed. Okay, because the door blew off a couple times and missed people. So yeah, hiring a former FDA investigator is a great thing. You know, there's people out there that do it that they're retired. Now, my claim to fame was I have undergone nine FDA inspections. I think I have the record and I call it face to face inspections, you know, like you're the one in the room. And so that's where I said I bring a unique perspective because I know where the skeletons are hidden. So when I would go and inspect companies doing this, I would know, you know, okay, if you want a good inspection, I'll do it for you.
But it may hurt. So what I would say is that there's people out there that will do this. Okay. So there's two types of people. There's people there, okay I'll do it. And you know, I'll give you my report and then you work on it, you know professional people. And then there's people that they'll hire the board of directors will hire and they'll, they'll say, I want to know everything because my name is on it. So, so yeah. And the FDA also, when they walk into a situation, it's a horror show. What will happen, especially if it's a big company go issue. It's called a consent decree, and in the consent decree that's a legal document to the Justice Department. And they'll tell you have to hire a third party consultant. And basically they don't trust you, you know. So you want a probation to you get out of it. So, you know, the FDA does recognize and value consultant because we occupy a position of, you know, less conflict of interest. So see we're coming to the end of the time. You know, we could do this again. I could talk forever, I was thinking of writing a book someday about this, but I'm not sure if anyone would buy it.
Closing Remarks and Lessons Learned 🔗
George Hattub: But anyhow, thank you everybody I really appreciate this opportunity. And don't change what you're doing in your job. I mean, what I see in Innolitics you're with the leadership and whatever. You know, it's just a great company a great career path. And so you know I'm not trying to scare you or anything. Basically what I'm trying to do is educate you. So if you ever decide to leave, you work for a company, you need to like, you know, do that due diligence, you know, as far as am I going to be the, you know, the sacrificial lamb if there's a problem or am I entering a small company, which I've seen plenty of small companies that have really good systems of checks and balances. Thank you everybody.
Mary Vater: Awesome. Thanks so much George.
George Hattub: Okay. Bye now. Thanks. Bye.
