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Insight Report Vol.8 No.2
FDA Affidavits
“To sign or not to sign” has only one
answer -
-------- YOU NEVER SIGN ! ! !
An Affidavit is defined as 'a sworn statement, and/or an official
declaration.'
Would you make a sworn statement or an official declaration
concerning a possible criminal action that you may have been involved in
without having your lawyer read it?
Then why is it so hard for company officials to just say, “NO” when
the FDA asks them to read and sign an affidavit concerning a possible
violation found at their company?
Whether it is a simple “sample collection” or part of a GMP audit and
the FDA is picking up records, the FDA will try to get a company
official (the highest level official at the company at the time is the
most appropriate), to sign an official declaration or a sworn statement
or as the FDA calls it an “Affidavit” to document that the records that
the FDA investigator is collecting are from that firm and how they
relate to the documents.
Over and over again, we try to make company officials understand that
signing an FDA affidavit is a major mistake. Yes, we know that when you
read the affidavit (that is actually prepared by the investigator) it
often appears as information that the investigator already had and it
usually only reiterates what was already discussed. But, signing an
affidavit only provides benefit to one party and that is the Agency. It
can only cause you potential problems. There are no benefits for the
person or company who signs this document.
Let’s take a look at how the FDA views investigational affidavits and
how they train the investigators on getting companies to sign these very
incriminating documents.
FDA’s guidance to the investigator on getting a signed affidavit
The FDA provides a guidance document to the investigators on how to
prepare an Affidavit and how they are supposed to get (or trick) the
company official to sign it and/or confirm that it was read and
understood. Yes, the FDA has taken the time and effort to train their
investigators in how to prepare and get the companies to sign these
official documents. This training and explanation for Affidavits is in
the FDA IOM (Inspector’s Operations Manual). As you will see the FDA
takes the affidavit preparation and signing to be a very important part
of any investigation or inspection.
The IOM states the following:
“Statements on various affidavit forms may be obtained from persons
who have dealt somehow with the goods sampled, know material facts
relating to the movement of the goods, and/or to events affecting their
condition. Such facts, recorded in writing and signed by the person who
can testify in court to those facts, can be used either to establish
federal jurisdiction or fix the responsibility for a violation. The
statement may identify documents proving I.S. movement of goods sampled;
it may name the person who could testify to the identity of the goods
sampled, and it may certify the sample collected is from the lot of
goods covered by the records.
The IOM goes on to state:
General considerations for
all affidavits
"You should have the affiant read the statement and make necessary
corrections before signing the affidavit. Mistakes, corrected, initialed
and numbered by the affiant are an indication he/she has read and
understood the statement. A handwritten statement by the affiant,
declaring he/she read and understood the statement is a valuable tool to
counter the possibility the affiant might later claim ignorance of what
was signed.”
Let’s stop here. Did you read what the FDA’s IOM states concerning
why they want the affiant to sign the affidavit and declare that it was
read and understood -
“it is a valuable tool to counter the possibility the affiant
might later claim ignorance of what was signed.”
In my opinion, this statement appears to be ominous.
Additionally the IOM goes on to state:
“Before the individual signs
the statement, ask him/her to affirm the affidavit is true and accurate.
A statement to that effect can also be added at the conclusion of the
affidavit.
You should only sign the
affidavit AFTER the affiant has signed it. The wording above your
signature is, "Subscribed and sworn to before me at ***" Subscribed , in
this context means to attest by signing. Thus, your signature is
attesting to the fact that the affiant has read and understood the
statement and has confirmed that the statement is the truth. You MUST
NOT sign an affidavit until after the affiant swears (affirms) to you
the written statement he/she has signed is true. If you provide a copy
of the affidavit to the affiant, you should keep the original affidavit
since the original is an official FDA document.
As you can see, that the FDA is possibly planning to use this
document for more than just a statement of fact by you concerning
something that the FDA collected or found in your documents during an
inspection.’
Now we get to the section explaining to the investigator what to do
in the event that the affiant refuses to sign the affidavit. You will
find this very interesting.
Refusal to Sign the Affidavit
- Even if it is apparent the affiant will refuse 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 affiant or
have him/her read it. Request the affiant to correct and initial any
errors in his/her own handwriting. Elicit from him/her an
acknowledgement the statement is true and correct. Ask him/her to write
at bottom of the statement "I have read this statement and it is true,
but I am not signing it because..." in his/her own handwriting.
The preceding statement shows that this affidavit must be considered
a very important document if the FDA has such detailed instructions on
how to deal with company officials who refuses to sign this document. It
is incredible that the FDA would try to trick someone to sign or attest
to something that you may think is very innocent. But it seems apparent
that the FDA believes that this is a critical and official document and
they have worked hard to figure out ways to get you to attest to the
validity of its content. Maybe you should give serious thought before
deciding to sign such a document in the future.
The IOM continues to instruct the investigator in what to do in the
event they are faced with a refusal for acknowledging the affidavit:
Failing that, declare at the
bottom of the affidavit that you recorded the facts above as the affiant
revealed them, that the affiant read the statement, and avowed the
statement to be true. Sign and date the statement in the body of the
document; only sign in the signature block if the affiant signs the
affidavit.
The IOM then explains how to deal with informants and affidavits:
Confidential Informants - You
should take special precautions when obtaining an affidavit from a
confidential informant, the affiant may be reluctant to sign a
statement, which reveals his or her identity.
So, getting back to the original questions, “Should you sign or not
sign an FDA affidavit when it is presented to you by the investigator?”
There is only one answer, “Do not sign!” Affidavits do not
provide the signer any benefits and could be very detrimental in the
long run.
If you have any questions on FDA Affidavits or any stories on what
the tactics that the FDA investigators tried to use to get you to sign
the Affidavit, please email us at
info@mdiconsultants.com .
Next Insight Report - The next Insight Report - “Warning
Letters review - FDA’s Present Policies”
If you
have any comments on these INSIGHTS we hope that you let us hear them. If you have any of
your own INSIGHTS that you feel would be of value to other companies, we would be pleased
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on this site for others to learn from.
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