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Compliance Corner: 20 Things You Should Never Say To An FDA Investigator

Executive Summary

Medical device manufacturers might be tempted to defend themselves during a US FDA inspection. But longtime industry insider Steve Niedelman says there are 20 instances in which firms should remain tight-lipped.

When being inspected by US FDA, a medical device manufacturer might be tempted to defend itself. But one longtime industry insider says there are certain things that shouldn't be said to agency investigators.

In a Nov. 3 presentation at FDAnews' 12th Annual FDA Inspections Summit in Bethesda, Md., Steve Niedelman ticked off a list of 20 things that firms should never say.

Niedelman – lead quality systems and compliance consultant at the law firm King & Spalding – is a familiar face in the medical device arena, working at FDA for 34 years in both its Office of Regulatory Affairs and Center for Devices and Radiological Health.

"You always want to present your company in a very positive way during an inspection. You want to be very confident. You want to be able to present and represent your firm in a productive and constructive way," Niedelman said. "So, here are 20 things never to say to an investigator so you can present yourself in the best fashion possible."

1. "I think…"

"Don’t ever say this. That just opens the door, just opens the Pandora’s box, to an opportunity for the agency."

2. "I am not sure."

"If you’re not sure, then you’re not confident. It's the same thing. If you provide the investigator information and say, 'I’m not sure of this,' then you’re suggesting to them that they have an opportunity to really dig in and start pushing further."

3. "I told them not to do it this way."

"Don’t throw your firm under the bus. If you say, 'I told them not to do it this way' – well, then why’d they do it? You’re responsible for what your firm has in its possession, so if you think it’s going to get you any brownie points from an FDA investigator perspective, it’s not. It’s just going to show that you acknowledge that things were done incorrectly. That’s not a good thing."

4. "You are wrong about this … you don’t know what you are talking about."

"When you tell the investigator this, that’s really not a good sign. There could be differences of opinion. You might not think they know what they’re doing. You may be able to say, 'Well, we respect your opinion, but we also respectfully disagree, and we went down this road,' versus saying, 'You guys have no idea what you’re talking about.'"

5. "During the last inspection, the FDA investigator saw the same thing and did not put it on the FDA-483 form."

"If you say this, then you just acknowledged that this problem has been ongoing for longer than the investigator may have been aware. And quite frankly, inspections are a snapshot in time. Investigators might not look at the same thing. Different investigators have different sweet spots. They have different areas that they’re more familiar with. And, not everybody is perfect. And so, first of all, you just threw another investigator under the bus, and that's not the best thing in the world to do. And by saying that this has been going on for a longer period of time, well, you just indicted your own firm again."

6. "The last investigator to inspect was crazy," or, "The last investigator to inspect did not know what he/she was doing."

"That doesn’t bode well. Again, there’s nothing to be gained by trashing a former on-site investigator."

7. "How would you recommend that we fix this deficiency?"

"FDA is not there to be your consultant. It just indicates to them that you really don’t know how to deal with your problems. They’re not going to give you an answer, so there’s nothing to be gained by asking this."

8. "That is the way we have always done it."

"Having bad practices doesn’t mean that it’s good. And sometimes, quite frankly, teaching an old dog new tricks is not easy, either. So, by saying, 'That’s the way we’ve always done it,' you’ve just incriminated yourself for quite some time."

9. "I probably shouldn’t say this, but…"

"Well, you know, if you probably shouldn’t say it, then don’t. If you’re going to be sharing information that you’re going to have a tough time corroborating later or that may come back upon re-inspection, or will be memorialized in an Establishment Inspection Report that you will have to defend later, then you probably should just keep it to yourself. You might want to share it with someone else in your organization, but not the investigator."

10. "If we followed those procedures we would never get anything done."

"Well, you know what? If your procedures are deficient, fix them. But you’re expected to follow your procedures. If you don’t, not only is the problem not having procedures, but not following them is just as bad. And I can tell you as somebody who signed off on every enforcement action at FDA for about a decade, whether it was a device or drug or food, or whatever, most of the firms, probably 80% of the time, their procedures might not have been the gold standard, but if they were followed, the firms would have been fine. In most of the cases, they didn’t execute their own procedures, and it resulted in enforcement actions such as seizures, warning letters and injunctions resulting in consent decrees."

11. "We don’t have enough people or time to review all of those complaints."

"Well, that’s a problem, but it’s also a double-whammy, because it also says management has not given appropriate resources to the quality department to be able to handle those complaints. If there aren’t adequate resources, that’s a management control problem, and in the medical device quality system, that’s the center hub of their quality system. So, you now have late complaints, improperly investigated complaints, and a management control problem because the resources aren’t there."

12. "The management of this firm is only concerned with profits and does not take quality seriously."

"That’s probably true in many situations, quite frankly. Let’s be honest. Management is concerned with profits. If they don’t have profits, they won't be in business. But management needs to be made aware of what the cost of poor quality is, and what the consequences of that are. I understand it’s sometimes difficult to push that message up, but the best goal is always for a quality mindset to cascade down from the very top."

13. "I do it this way because our procedure does not make any sense."

"Well, have you made anybody aware of that? What are you doing to change the procedures so they work? What changes need to be made? Are you just living with them or are you even following them? If that is the case, whatever you do, don’t make FDA aware of that.

14. "I will change the procedure right away."

"Well, you should have change procedures to handle that. Don’t say to the investigator, 'Oh, we’ll have that changed by tomorrow' just to make a pen-and-ink change, or whatever is necessary. You have to be able to establish that you’re following your procedures, and that your procedures are not just ad hoc decisions that anybody could make willy-nilly, even if an investigator points out a problem. Instead, say, 'Thank you for pointing that out. We will review it. It will go through our change process as we feel it’s appropriate."

15. "If you think that’s bad, you should see this…"

"That’s not a good situation. The investigator found something bad; don’t point them to other things that are bad. Instead, take your lumps on the one thing that’s bad and don’t open the kimono for everything else that’s going on. Because if you do, that inspection will just grow. What may have started as what was intended as a week inspection, well, FDA could now be in there for six months. You want to avoid that."

16. "We fixed the problem by firing the person."

"There are certain situations where firing certain personnel is a good thing. It may change the culture of an organization. But chances are, firing the person wasn’t the problem. The inadequate procedures were; the quality system in place was. And if the new person is going to follow those same procedures, then you didn’t gain anything. It's important to keep that in mind."

17. "That’s not my fault. It was the previous person who did that."

"Well, quite frankly, you’re the person. You’ve been in that job. You knew there was a problem. You had an obligation to fix the problem, or at least take steps to fix it."

18. "That’s not my problem … that is quality assurance’s problem."

"You know what? Quality is everyone’s business. If an investigator is pointing out a quality issue to you, then you need to make it your business. You need to make sure that the appropriate people in your firm are aware of the problem that was identified, as well. Quality’s everybody’s job; everybody has a role. Everybody contributes to it, and you can’t just say, 'Ignore it, because it’s not within my bailiwick.'"

19. "Write it on the FDA-483 form because that is the only way we will correct it."

"There are firms that, if it doesn’t appear on the FDA-483, then it doesn’t get anybody’s attention. Of course, you don’t want to tell the investigator you do that, but again, that’s a quality culture issue within your firm that desperately needs to be addressed."

20. "Are you going to shut us down, or are we going to get a warning letter?"

"Don’t ask investigators that because they don't make that decision. They're just the eyes and ears. They collect the information, and it's reviewed by their supervisors and compliance officers, and perhaps at the senior level beyond that."

From the editors of The Gray Sheet

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