How To Write A 483 Response – The Basic Rules
There are some basic rules that can be established regarding writing a FDA 483 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.
- Someone in a high level in a Quality group (internal or external) should write the response.
- 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.
- 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.
- 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.
- Re-state the observation and reference number in the response. Typically, the observation goes directly above the response.
- If possible, indicate the related compliant systems. This shows that you are in control and that some operations were functioning within acceptable GMP parameters.
- 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.
- 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.
- Define how enhancements will prevent recurrence of the issue observed. Don’t assume that the reader will understand this fact.
- Explain what will be done to expand, enhance or streamline the compliance system.
- Don’t forget about training. Allow sufficient time to implement changes to incorporate training that may include proficiency testing.
- Describe how the firm will monitor the progress and effectiveness of the corrective actions.
- 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…”
- 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.
Next – Format of a FDA 483 Response
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