A guide for how to survive a FDA Warning letter. So you got at FDA 483 and now you have a FDA Warning Letter, learn how to survive the storm. For more information go to http://compliance-insight.com/fda-483-warning-letters/

1. A Compliance Officer’s Guide to Surviving the Storm
Compliance Insight, Inc. 513-860-3512 Copyrighted 2013

2. What is an FDA Warning Letter
The United States Food and Drug Administration defines a Warning Letter as
"...a correspondence that notifies regulated industry about violations that
FDA has documented during its inspections or investigations. Typically, a
Warning Letter notifies a responsible individual or firm that the Agency
considers one or more products, practices, processes, or other activities to be
in violation of the Federal Food, Drug, and Cosmetic Act (the Act), its
implementing regulations and other federal statutes. Warning Letters should
only be issued for violations of regulatory significance, i.e., those that may
actually lead to an enforcement action if the documented violations are not
promptly and adequately corrected. A Warning Letter is one of the Agency’s
principal means of achieving prompt voluntary compliance with the Act.”

3. • Documents a violation of law or regulation
• Establishes that a firm or person has been
notified of the violation
• Your response to the FDA 483 may have been
deficient
• Designed to promote voluntary compliance
• Stepping stone to regulatory action

4. What does this letter mean for
you and your firm?
• Warning Letter is considered to be “prior
notice”
• Respond within 15 days
• FDA will initiate necessary action if no
response is received
• Time is CRITICAL – you have to organize,
understand, resolve and respond to the FDA

5. Before we begin on the response
work, let me say a few words about…

6. Two Approaches To Assessment
Focused
Assessment –
Based
specifically on
items from the
Warning Letter
Overall
Systemic
Assessment –
Look beyond
the specific
items, other
areas/products

7. Writing the Response
There are some basic rules that can be established
regarding writing a response letter. Some or all of
these rules may apply depending upon the particular
situation of the firm – e.g. lengthy list of
observations, serious issues on the warning letter,
etc.

8. Writing the Response
1. Someone in a high level in a Quality group (internal or external)
should write the response.
2. Personnel copied on the response should include high-level
management. This shows that management at the firm is aware
of the issues and the commitments being made.
3. Include a cover letter or opening statement. Tell the FDA that
you are serious about resolving the issues. State the site
address of the audit and the dates.

9. Writing the Response
4. Always remember that you are writing the response to the auditors
management – governmental auditing bodies do have supervisors and
managers. Do not assume that the person reading the report
understands the context of the observation or your reply.
5. Re-state the observation and reference number in the response.
Typically, the observation goes directly above the response.
6. If possible, indicate the related compliant systems. This shows that you
are in control and that some operations were functioning within
acceptable GMP parameters.

10. Writing the Response
7. If the action item is going to take some time to implement, state what
will be done in the interim to be compliant with GMPs. Don’t simply
indicate that actions will be taken in six months to correct the issue in
which you are currently out of compliance without addressing what you
will do to be compliant from the current date until the corrections are
implemented.
8. If corrective actions have already taken place, indicate the following:
• Dates implemented
• Training performed (copies of training sign-up sheets included)
• Copies of Purchase Orders, installation work, etc.
• Copies of updated SOPs – indicating what was changed.

11. Writing the Response
9. Define how enhancements will prevent recurrence of the issue
observed. Don’t assume that the reader will understand this fact.
10. Explain what will be done to expand, enhance or streamline the
compliance system.
11. Don’t forget about training. Allow sufficient time to implement
changes to incorporate training that may include proficiency
testing.

12. Writing the Response
12. Describe how the firm will monitor the progress and effectiveness of the
corrective actions.
13. It may be helpful to explain that despite the issues noted, there has never been
an issue. It is not advisable to use this response tactic each time but it can be
advantageous for critical observations to state something on the order of “…the
product has always met predetermined quality parameters…”
14. Revise, revise, revise. Allow other people not directly involved with the audit to
review and comment on the response. They may have insight on response
wording that would assist in clarification or strengthening of points.

13. How the response should look

14. Indicating corrective actions – taken or
planned
Restating the observation or
comments
Defining root cause
Developing the due date
When initially formulating a response, a 4-Stage Inspection Response
Approach may be helpful to develop perceptive on the format of the
response and contribute to a better understanding of what actually needs to
be implemented to be compliant. This type of approach includes
Item
1
Item
2
Item
3
Item
4

15. Cover Letter Example – this is
from top level management…
We are in receipt of your communication dated --- on -----. We take your
communication very seriously and commit ourselves to address your
concerns adequately and expeditiously. We will take all the necessary
measures to ensure our customers' well-being and safety. Enclosed please
find an attachment that addresses your concerns on an individual and on a
systematic basis.
We agree that a sound Quality System is the result of effective
management commitment, dedicated employees, and sound processes
and practices.
To that end we have retained _____, a reputable consulting firm, to assess
our Quality System in greater detail and to help ensure that our Corrective
Action plan will address all systemic issues effectively. We have attached a
qualification profile for your review.

16. Response Letter – from the
response team
xx June 20xx
U.S. Food and Drug Administration
c/o <name>, Compliance Officer
<address>
<city>, <state> <zip>
Re: Warning Letter xxx
Dear Mr. xxx:
This letter provides the response from <company name> to the Food and Drug Administration’s (FDA) Warning Letter dated xxx
(Attachment 1) related to findings from FDA’s inspection of xxx facility on xxx through xxx. As the Warning Letter notes, xxx
responded to the FDA Form 483 on xxx (Attachment 2 for the 483 and original response) but notes that it “did not provide any
detailed information regarding proposed corrective actions.” To address this point, xxx is also including a more in-depth response, as
part of this letter to the original 483 observations.
xxx takes seriously its responsibilities in providing a quality product to the public. It continues to be xxx objective to operate in
accordance with current regulations as stipulated by the US FDA. We value your communication and commit to meeting current
GMP requirements. To this end, xxx has executed xxx critically important actions:

17. W.L. Observation
During the inspection, our investigators observed and documented xxx conditions. An analysis of your xxx
collected during the inspection found significant xxx contamination.
Response
In conjunction with the conditions noted, xxx has initiated the following:
xxx
Implementation and maintenance of a clean and compliant environment has been executed as detailed
previously but includes the following highlights:
xxx
Pursuant to the situation as outlined by the FDA testing of the xxx, xxx initiated a recall of the lot in xxx.
The investigation into the situation that caused this incident indicated the following highlights:
xxx
Root Cause of the Situation:
xxx
Action Plan
As applicable…
Due Date

18. Beyond the Context of the Direct
Observations
• A systemic response to any audit observations must equate to a
systemic resolution to any issues within the firm.
• This action requires further evaluation than just actions in a
system at a company site.
• The FDA in particular will require that all company sites implement
corrective actions along the same plan of action.
• Failure to do so may result in further regulatory actions.
• Programs need to be established which require any observations
and the responses to be circulated for evaluation within a
company to determine if other areas are non-compliant.

19. Be Sure to Visit Us On-Line or Call…
Our website is filled with lots of tips
and guidance on FDA 483’s, Warning
Letters and more. Visit us at:
www.Compliance-Insight.com
You can easily contact us for more
help in dealing with FDA Warning
Letters by calling us at 513-860-3512

20. www.Compliance-Insight.com
Call us at 513-860-3512
Email us at
FDAWarningLetterTeam@Compliance-Insight.com
Questions? Comments?
We are happy to help you!