Company insight Dealing with the FDA
With the FDA beginning to inspect medical companies once again following a slow down due to Covid-19, it is important – especially for new companies – to know what to do when faced with a representative. Alan Schwartz, executive vice-president of mdi Consultants, offers expert advice on how to deal with the FDA investigator and their issuance of an affidavit.
T
he FDA is back visiting companies and doing on-site inspections again following a long hibernation
after Covid-19. We are finding that many companies are not ready to deal with these visits. This is especially true when it comes to new or smaller companies.
Dealing with the novice investigator
This post-Covid era has the FDA working with many new or novice investigators. There is, understandably, concern for a new company about how to deal with these investigators and the inspection itself. Many times you will see these investigators having to be in close contact with their supervisors on what documents to review and what to collect. This makes the inspection run longer and seem erratic because finally decisions are made by the office and not the investigator in the field. Companies have to be prepared to deal with this situation and put up with a drawn out inspection. Two major areas of concern during these inspections are the issuances of the affidavit and responding to the 483.
Getting it in writing
What is an FDA-prepared affidavit? The FDA usually prepares these affidavits when they want to document what it reviewed about a company and/or interstate shipments that a company has made. So what is this affidavit for? It is to make the FDA’s job easier. Once signed (by the company’s official), the FDA has a written proof that the company was familiar with the supplied documents and attests to their accuracy.
The FDA finds this evidence to be very worthwhile or it would not go out of its way to prepare the affidavit and then intimidate the company’s official into signing it.
The FDA wants to get an affidavit whenever possible to make its job easier. The investigator will use tricks to get you to sign and/or acknowledge you read and understood the affidavit. Do not acknowledge, read or sign an affidavit. This affidavit is a self- incrimination by the company official who signs it.
As already mentioned, a company should have a policy on dealing with FDA affidavits. This policy should read
“Do not acknowledge, read or sign an affidavit. This affidavit is a self-incrimination by the company official who signs it.”
The FDA affidavit
One of the areas that FDA-regulated companies should be aware of is how to handle an FDA affidavit. Having a policy on how to deal with the FDA during inspections is an important first step in being prepared. This policy should also address what to do if the FDA wants you to sign an affidavit.
something like the following: “No company employee may acknowledge or sign affidavits issued by FDA personnel. Affidavits are written by the investigator to document what evidence he/she collected at the firm.” This affidavit will not be of any value to the company, only the FDA. It could be used at a later date to indicate that the company supplied this information and that it has the
Medical Device Developments /
www.nsmedicaldevices.com
affidavit from the management attesting to this.
Knowing what to do It is important to be aware that not signing an affidavit is in no way an inspectional refusal, although the investigators will try to make it appear so. You could ask the investigators where it states that you must sign an affidavit. If an affidavit is prepared, attempt to make a copy, but try not to let the investigator know you are doing so. Let the investigator know that it is your company policy that all affidavits have to be reviewed by corporate counsel before a signature can be made. Again, the affidavit will only benefit the FDA and could later cause damage to the company.
The 483 response
An affidavit is not the only thing a company should be aware of when dealing with the FDA inspection. One of the most important areas of concern is preparing the response to the FDA issued 483 (List of Observations) at the conclusion of its inspection. This response will be read by the investigator’s supervisor and/or the compliance officer. It is critical that your response addresses each observation as a standalone item. Make sure the response addresses the observation. First, is the observation correct? If not, address that point and why it is not correct. If the observation is accurate, how will you correct it? Following this, you need to supply the documentation showing the correction was made and how you will avoid this problem reoccurring.
This is the last chance to prevent the FDA’s next level legal action – a warning letter.
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