Easy Mistakes To Make During An FDA Inspection
By Dan Schell, Chief Editor, Clinical Leader
If you’re in the clinical trials field, and you’re interested in helpful and insightful information regarding a myriad of regulatory issues, Vin Cafiso’s LinkedIn posts can be viewed as nothing short of a goldmine. That’s because he frequently doles out nuggets of wisdom he’s gathered during his nearly six years as an FDA investigator. But even Cafiso was surprised when his post, “20 Things Never to Say to an FDA Investigator,” produced 278 comments and 141 reposts (as of July 22, 2024). Here’s his list:
- "I think…”
- “I am not sure but [insert guess here] …”
- “I told them not to do it this way…”
- “You are wrong about this … you don’t know what you are talking about…”
- “During the last inspection, the FDA investigator saw the same thing and didn't put it on the 483…”
- “The last investigator was crazy” or “The last investigator didn't know what they were doing…”
- “Well then how would you recommend we fix this deficiency?”
- “That is the way we have always done it…”
- “I probably shouldn’t say this, but….”
- "If we followed those procedures, we would never get anything done.”
- "We don’t have enough people or time to review all those complaints…”
- "The management of this firm is only concerned with profits and does not take quality seriously."
- “I do it this way because our procedure does not make any sense."
- “I will change the procedure right away.”
- “If you think that’s bad, you should see this…”
- “We fixed the problem by firing the person.”
- “That’s not my fault. It was the previous person who did that…”
- “That’s not my problem, that is quality assurance’s problem.”
- “Write it on the 483. That is the only way we will correct it.”
- “Are you going to shut us down" or "Are we going to get a Warning Letter?”
At the end of his post he asked readers what they would add to his list. After the comments poured in, Cafiso pulled out from that list an additional “20 things…” and then posted that along with attribution for each entry. Do yourself a favor and read that list; there are some doozies on there!
Now sure, on each list there were entries that were obvious. For instance, you’re only setting yourself up for more problems if you start criticizing the investigator (#4) or blame quality deficiencies on the company’s management practices (#12). But, I thought #7 and #14 in that first 20 could be instinctively what you would say when talking with an investigator. Reading through other comments, I started to think the best practice was what one attorney suggested — just don’t say anything. “No, you have to interact,” Cafiso said with a laugh during our interview. “At some point the investigator is going to want an answer to their question.”
WATCH WHAT YOU SAY
Of course, FDA investigators are trained to find red flags during an inspection. And yes, sometimes what the person interacting with the investigator says can uncover a red flag. But even your choice of who is going to be in the room with the investigator can influence the inspection. If the employee is burnt out or generally frustrated with the company, those feelings are going to seep into their interactions with the investigator, and in turn, will plant a seed with the latter that there may be deeper issues at work in the organization affecting quality.
Then there’s the situation where you have a seemingly dedicated and happy employee who, when told of a quality issue, says things like, “How can we fix that? I want to make sure the next time we have an inspection, the same problem isn’t found again.” Or, “I'm going to fix that procedure right away.” Those types of responses may seem almost automatic or genuine for many people. What your staff need to understand, though, is that the investigator is not there to help you solve the problems they have uncovered. “To an investigator, those kinds of questions and responses could demonstrate a lack of critical-thinking skills or even a lack of understanding the quality requirements,” Cafiso says. “In turn, that could lead the investigator to question if this person is in the right role. Remember, the investigator is trying to discover exactly what led to a particular issue. And by simply suggesting putting a ‘Band-Aid’ on something by just updating a procedure, the investigator will perceive that as the not taking a systemic approach to identifying the true root cause of the problem.”
So what can you say that’s going to be “safe?” Cafiso plans to do another long LinkedIn post on this exact subject, so I don’t want to steal his thunder here, but I will share that he says to just try and answer any questions to the best of your ability. Don’t elaborate if you don’t have to, and don’t let silence in the room lead you to ramble on. If you’re unsure of something, say that, and find the answer, preferably by showing the investigator the document pertaining to the question.
WHO SHOULD BE IN THE ROOM?
Ideally, you should have a plan for who will be in the room with the investigator — before they arrive on your doorstep. The worst practice? Have someone usher the investigator into a room and tell them to hit zero on the phone if they need anyone for the duration of their inspection. Don’t do that.
Instead, Cafiso suggests always having two people with the investigator. Assign one person to be the inspection host, also known as the “front room lead.” They’re the investigator’s main point of contact. Then, most companies will have another person assigned to be a “scribe”, who would be typing what's being talked about and asked for. Sometimes those notes are being sent electronically to other people in the company. “I've seen companies overdo it, where they have a complete entourage in the front room with the investigator. I don't advise that,” he says. “I think there is a certain level of commotion and distraction that's associated with multiple people in a room. I've seen people have the host, the scribe, and a separate person who I would call a log keeper; somebody who just writes down every time the investigator asks for something like, ‘Hey, could I get that procedure? Could I get those records? Can someone bring me in the org chart?’ There could also be a runner who gets up and retrieves whatever is needed. So you could have four people in addition to the investigator. Again, not my suggestion, but I do see companies doing that because at the end of the day, the investigator is there to have his or her answers or questions answered in the quickest way possible.” Of course, some companies simply put the investigator in the room with all their original documents, thereby eliminating the need for runner.
LEAVING THE FDA
Cafiso says he eventually left the FDA because he did want to help many of those companies that asked him for advice or help during an inspection. He recalled one experience where he had three competing companies all in the geographic region he covered as an inspector. Over the years, during his inspections of each one, he would notice they all would be doing some part of their process exceptionally. “You want to be able to tell a company, ‘Hey, your competitors down the block? They're doing it so much better than you. Here's what they're doing. You should just do it this way.’ But you can’t as an inspector. So, I left to become a consultant — but it took me 25 years to get here! [He worked in various quality-related roles for multiple companies before becoming a consultant this year for CREO.]
In one of his most recent LinkedIn posts he talks about the cost of 483s. During our interview, he also spoke about what happens after an inspection if you get a 483 (expect one, he says!). Check out this video of him explaining the whole process of how to respond.