REGULATORY OUTLOOK
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Don’t offer more than asked. Think first before answering a question to be sure you understand it and know how you’re going to answer. If you’re not sure what is being asked, clarify with the investigator. If the FDA investigator doesn’t respond, just wait until he or she does. If the investigator doesn’t comment after you’re done answering a question, wait for a comment. The normal rules of social interaction don’t apply during an inspection. Frequently, an investigator will allow an uncomfortable pause during questioning to try to prompt you to talk more. Don’t take the bait.
Clarify what is being asked. If you don’t understand what was asked, clarify the meaning or purpose of the question. If the question seems overly broad, ask for specifics. Most importantly, if the implication of the question seems wrong, clarify the context of the question or the reason for it.
Try to limit fishing expeditions. FDA often asks broad questions. Try to narrow the scope of the response. For example, if the investigator says, “I’d like to see your complaint file.” You could respond, “For what year?” or “For what product?” or, “Are you looking for a particular type of complaint?” Responding with a question helps your situation in two ways. First, you show you want to assist FDA in looking at complaint files. Second, the investigator cannot respond with a yes or no answer. Keep in mind that the investigator has the right to ask for all the files, but more often than not, a question will help refine the request.
If you do not know the answer to a question, say so. It is all right not to know the answer. The best response is to find the person who does know the answer or to find the answer, if it’s appropriate for you to do so.
Refer to written procedures as you are answering questions. Rather than looking like you don’t know what you’re supposed to do, referring to procedures shows that you use them on a daily basis as you go about your work. When you don’t refer to them, it can send a message that they’re unimportant and are seldom used.
Don’t argue, but rather, discuss. On the same note, don’t be afraid to question the investigator. If you are the subject matter expert or the person responsible for a department, explain your company’s procedures and practices without apology. If the investigator finds fault with your company’s procedures, ask for an explanation of the concern to be sure you understand it.
Ask the investigator whether he or she sees anything of concern. FDA may or may not answer. Understand that the investigators are human. Some will share what they’re thinking and others won’t.
If FDA asks for a copy of something, make a duplicate copy for the inspection file. It’s usually easiest to keep copies filed by the date they were provided. Don’t destroy the inspection file when the inspection is over. Your record retention policy should dictate how long the inspection file is kept.
If FDA takes a physical sample, take a duplicate physical sample. Although it is not common during medical device inspections, be prepared if FDA does take a sample.
If the investigator is willing to do a daily debrief, take advantage of it. During a debriefing, make sure you understand what the investigator is observing. If you think the investigator has misunderstood something, offer to provide additional information or explanation. If the company has decided that a corrective action is necessary based on what the investigator has found, let the investigator know that the company agrees and is planning corrective action.
