FDA Inspections: How to Respond to a Request for an Affidavit

By Alan P. Schwartz, Senior Partner, mdi Consultants

Dealing with the FDA during an inspection could cause real emotional stress to say the least. Should you respect the request of FDA investigator if you are not sure what the consequences would be at a later date? What damage would it be to sign an affidavit if it appears to state the truth? These are questions that could come up during a visit by the FDA. How you deal with them could be very detrimental to you and your company. Knowing what NOT to say is just as important and sometimes even more important than know what to say. And that also applies to whether or not you should sign an FDA affidavit.

It appears, from recent FDA inspections at which we have been present, that FDA investigators are intending to use the affidavit to document the interstate shipment of the medical devices to support future legal actions.

It should be your company’s policy that “company employees are not allowed to acknowledge or sign affidavits issued by FDA personnel.” Affidavits are written by the investigators to document evidence collected at the firm. This affidavit will not be of any value to the company – only to FDA. It could be used at a later date to indicate that the company supplied this information and that the agency has an affidavit from company management attesting to this.

There is no requirement to sign an affidavit. Refusing to acknowledge or sign an affidavit cannot be considered a refusal to cooperate, though the investigators will try to make it appear so. You could ask the investigators: “Where does it state you have to sign an affidavit?” They will not have an answer.

FDA investigators have been trained to do everything in their power to get you to sign or acknowledge the information on an affidavit. FDA’s Investigations Operations Manual (IOM) Chapter 4, states: “Have the affiant read the statement and make necessary corrections before signing the affidavit. Mistakes that have been corrected, initialed and numbered are an indication that he/she had read and understood the statement.” It goes on to state: “A concluding paragraph in the affiant’s own handwriting declaring that he/she read and understood the statement are valuable safeguards to counter the possibility that he/she might later claim he did not know what he/she was signing.”

FDA’s IOM goes on to say that before the individual signs the statement it should be sworn to by asking the person: “Do you swear (or affirm) that this statement is true?” I have never seen an FDA investigator actually make that request.

Concerning refusal to sign, the IOM states: “Even if it is apparent that the company refuses to sign a statement setting forth the facts he/she has revealed, the statement should be prepared as described above. Either read the statement to the company or have him/her read it, preferably before a witness. Request the company to correct and initial by his/her own hand any mistakes. Elicit from him/her an acknowledgement that the statement is true and correct. Ask him/her to write in his/her own hand at bottom of the statement, ‘I have read this statement and it is true, but I am not signing it because….’ Failing that, declare at the bottom of the affidavit that you recorded the facts above as the company revealed them, that the dealer read the statement, and avowed the statement to be true. Attempt to have any witness to the statement sign the affidavit with his/her name and address.”

If FDA prepares an affidavit, you should attempt to make a photocopy of the affidavit, but do not let the investigator know you are making a copy. Tell the investigator that all affidavits must be reviewed by corporate counsel before they can be signed.

Again, it should be your company’s policy to not acknowledge an FDA affidavit. If the investigator attempts to have you hear or sign an affidavit, tell the investigator that he/she could read the affidavit to you but that you will not acknowledge any facts as to whether they are true or false. If you make this statement before the investigator has a chance to read the affidavit he/she might attempt to scare you by stating that you are refusing to cooperate. Do not fall for that trick.

REMEMBER: The affidavit will only benefit FDA and could later cause damage to your company. Refusing to participate in this exercise could be of real value to y