How to succeed when you get a FDA 483 form letter. What to do and how to handle your FDA 483. For more information go to http://compliance-insight.com/fda-483-warning-letters/fda-483-observations/

1. FDA 483 Observations
Resolving the Issues
Compliance Insight, Inc. 513-860-3512 Copyrighted 2013

2. What to do now?
If you are reading this now, you are probably in the middle of
some sort of FDA enforcement issue. Responding to FDA 483
observations can be one of the most important, and most
challenging, activities in your career and the company’s
history.
Failure to ensure a proper response and failing to clearly
indicate to the FDA that you are in CONTROL can be fatal to
your business.

3. Writing the Response – 14 Points
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
from a governmental body, client audit,
warning letter pending, etc.

4. 14 Points to Success
1. Someone in a high level in the Quality Department 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. Thank the
auditor(s) for being professional, providing insight or
other appropriate remarks as warranted. State the site
address of the audit and the dates.
4. Always remember that you are writing the response to
the auditor’s management – governmental auditing
bodies as well as clients. Do not assume that the person
reading the report understands the context of the
observation or your reply.

5. 14 Points to Success
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.
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.

6. 14 Points to Success
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.
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.

7. 14 Points to Success
11. Don’t forget about training. Allow sufficient time to
implement changes to incorporate training that may
include proficiency testing.
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.

8. 7 Actions to Avoid
Although the following information is not an exhaustive list,
there are some strategies taken by firms that indicate to an
auditor the firm’s unwillingness to change or inability to make
appropriate corrective actions.
If a firm does not have the capability, time or experience to
respond appropriately to an audit (especially a government
audit), a prime directive should be to seek outside assistance.
AVOID – At all costs!

9. Pathway to Disaster
1. During the closeout or in the response letter, argue every
point in that “they are not appropriate” or “we have
never had an issue with this point from other auditors”.
This is called a “scorched earth” policy and will ensure
that the auditor has a strong message of non-compliance
to the auditor body.
2. State that the corrective actions being requested will “put
the firm out of business” or “drive jobs to a foreign
country”. It is a scare tactic that has been used for at
least 20 years and has not proven to be the case.
3. The “rain forest” or overwhelming response. Include
massive amounts of data that is not warranted with the
hopes that the reviewer will be “impressed” with the
work. This type of response sends an immediate warning
signal to the auditor that issues are being glossed over.

10. Pathway to Disaster
4. Implement changes immediately. Either during
the closeout meeting or with a quick response,
all changes have been implemented for complex
issues. If the issue is simple, great – no
problem. However, for complex observations, a
rapid response indicates that the firm has taken
a knee-jerk reaction and implemented
corrective actions without thinking of the root
cause.
5. Not responding to the audit. Actions may be
taken but no formal letter is sent indicating
what was performed. This approach indicates
that the firm does not take the audit seriously.

11. Pathway to Disaster
6. The enigmatic response. The firm indicates that
actions are going to be taken but does not
address what these actions include. Such an
example would include: Actions Taken –
Records were updated. When? How were they
updated?
7. Promise without substance. Similar to the
enigmatic response, this approach does not
indicate any specifics. An example includes:
Deficiency – Detailed investigation not
performed in a timely manner. Response –
Investigations will be carried out in a timely
manner.

12. Assess Systemically
Resolve Issues or Plan to Resolve –
Systemically, across all sites
Finish the Response – If serious enough,
follow-up with your district office
Verify – that the resolutions worked
The FDA 483 – Phases to Resolve
Phase 4
Phase 1
Phase 2
Phase 3

13. The Choice is Yours!
Work diligently now or face serious issues
in the future

14. Questions? More Information?
Compliance Insight, Inc.
www.Compliance-Insight.com
513-860-3512
FDA483Team@Compliance-Insight.com
We have a significant source of information to help you on
dealing FDA 483’s – Contact us for a free consultation.