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How to Respond to an FDA Warning Letter or 483
The FDA writes warning letters in response to
violations of the Federal FD&C Act, or other acts. Failure to take prompt
appropriative, corrective/preventive action can result in enforcement action
without further notice.
This action may take the form of:
-Injunctions,
-Civil Penalties
-and possibly Criminal Prosecution
If your organization gets a warning letter consider it
a serious threat to your company. In recent years the FDA has relented somewhat
in their issuance of this form of notification but there is indication that the
practice may be on the rise. Organizations who receive them have seen their
stock drop dramatically. The cost of not actively working to prevent FDA
warnings can not be underemphasized enough.
483s
Receiving a 483 is in itself a mild slap on the wrist (compared to receiving a
warning letter). However, an organization must take the observation serious.
Failure to correct problems identified by the FDA can in itself lead to warning
letters.
ADDRESSING FINDINGS:
483s
Receiving a 483 is not the end of the world! It happens. It is analogous to
receiving a finding on an internal audit – how many times does that happen!
However, it is important to respond to the observation(s) in a concise manner.
First, a 483 is called that because it is the number of the form the FDA uses to
address observations – not to be confused with 482 which is the form the FDA
gives you at the beginning of all audits. The observations will be listed on the
483 form.
Address Every 483 Item
It is important to list the observations individually and respond to each and
every one. Some observations may be listed together in a string of sentences. It
is important to pull out each separate requirement/deficiency and then to
respond.
Content of a 483 Response
Your 483 response should be a planned corrective action. You are about to show
the FDA how your organization intends on correcting the problem. If you have any
questions regarding a finding – especially if there appears to be some ambiguity
or confusion – it is important to establish contact with the FDA officer who
conducted the audit and ask to restate the observation.
Your planned corrective action should have an estimated time of the steps
involved in resolving the deficiency – including the time expected for
completion.
Finally your response should indicate that you will forward evidence to support
the correction (new procedure, training records, etc).
If you are not sure how to respond to a 483 - DON'T -
HIRE A PROFESSIONAL TO DO THIS FOR YOU! Experts like Quintiles make a
living responding to FDA and have experts usually in the form of ex-FDA'ers to
help. It is worth the money.
Responding to Warning Letters
If you received a warning letter the first thing is to stay calm - Don't Panic
Rushing in to correct problems without first doing your homework can have
disastrous consequences. Sometimes it helps to hire an outside consultant to
help address and reply to the warning letter. This removes any of the emotions
attached with the impact of having received the warning. Get an
experience firm that deals with this sort of thing (like Quintiles).
Responding to a warning letter is essentially similar to responding to a 483.
There are some more (difficult) steps involved. First, you want to expedite your
response. In some cases an expedited response may mean the cessation of product
import restrictions or the end of a ban on sales. This alone usually gets an
organization moving to correct the deficiencies.
Unlike the response to a 483 in which the Agency may take your word on the
corrective action, in many instances a warning is usually followed up by another
FDA audit. It is extremely important that you “clean” up your act substantially.
You are not going to get sympathy for not correcting deficiencies. Sometimes it
helps to go above and beyond what is required – to give the Agency the sensation
that your organization is serious about fixing problems.
Conclusion
In conclusion make sure you have a definite plan on the resolution of any FDA
observations. If not clear on the finding make sure you have the FDA explain it
to you again. Act prudently but promptly to all observations. And finally, give
the FDA a sense that your organization is sincere in it’s desire to correct the
problem.
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