483 Response Letter - Are there any Special Formal or Content related Requirements?

[Aphel]

Hello,

Last week my company experienced an FDA inspection the first time.
It went more or less ok, but we still have some 483 observations to correct, and we promised to give respond within 15 days in writing a letter.

My question now ist...are there any special formal or content related considerations we have to think of?
Is there a certain form for writing this letter? What are your expriences?

I am going to write the letter the following way:

- Declaration of willingness to fully comply with the law
- Listing each single observation and discussion item
- Explanation how we are going to correct the issues:

root cause, measure, verification of measure, effectivness evaluation
(so we start a CAPA for each issue)
- complete timetable for implementation all actions

In your opinion - would this be ok? Thank you very much...


Best regards,
Aphel

 

[Gert Sorensen]

Re: 483 Response Letter

Your approach looks pretty solid to me. Be aware, that FDA is not easy to please, as is obvious when reading their warning letters. You may benefit from spending a little time browsing through some of those. Searching for "not adequate" may help you to narrow your results to some that may be relevant.

One advice though: Do not take an approach that may be seen to be confrontational. Consider the 483 an opportunity to improve your system, and the awareness of the QMS, and make sure that your response to the FDA reflects that.

 

[William_55401]

Re: 483 Response Letter

You are on the right track. The suggestion I make is not to include root cause overtly in the letter / on going correspondence. Let your CAPA investigation get you to root cause. You may find that what you thought was root cause when you write the letter is not what the team finds as they make progress on the CAPA. It also is good practice to focus on the actions (in the letter) and not focucs on root cause. It keeps the tone more positive and forward looking.

 

[v9991]

Re: 483 Response Letter - Are there any special formal or content related considerati

i agree that your approach is well rounded...however, hear the recommendations right from agency... and also an quick refresher on the impact/importance of EIR and related responses is appropriate. viz.,

8 suggestions for effective response...
1. Include a commitment/statement from senior leadership
2. Address each observation separately
3. Note whether you agree or disagree with the observation
4. Provide corrective action accomplished and/or planned; tell FDA the plan
? Be specific (e.g. observation-by-observation)
? Be complete
? Be realistic
? Be able to deliver what you promise
? Address affected products
5. Provide time frames for correction
6. Provide method of verification and/ormonitoring for corrections
7. Consider submitting documentation ofcorrections where reasonable & feasible
8. BE TIMELY

especially the pdf ppt from FDA...
&others at http://www.fda.gov/ICECI/Inspections/FieldManagementDirectives/ucm096015.htm

 

[MIREGMGR]

Re: 483 Response Letter - Are there any special formal or content related considerati

My observation from reading many Warning Letters is that the most common reasons why a 483 response isn't successful, resulting in Warning Letter issuance, are that the initial response is later than the deadline or incomplete, or that evidence of implementation and effectiveness of the discussed/promised actions isn't provided when promised or at all.

 

[tallu]

Re: 483 Response Letter - Are there any special formal or content related considerati

Dear Aphel,

I would like to hear the out come of your 483 response letter. Did FDA approved it?

Or did you have to provide more detailed information to FDA?

 

[Aphel]

Re: 483 Response Letter - Are there any special formal or content related considerati

Hello tallu...

FDA was satisfied with all our 483 responses...and the agency has closed our inspection last month...so we had to wait at least 10 month before they informed us and they sent us the EIR.
I want to give you one important advice: do not underestimate the work and the effort necessary to prepare the 483 response letters...it was really a though time.

Best regards,
Aphel

 

[Ajit Basrur]

Re: 483 Response Letter - Are there any special formal or content related considerati

Thanks for your response, Aphel

 

[Ronen E]

Re: 483 Response Letter - Are there any special formal or content related considerati

My observation from reading many Warning Letters is that the most common reasons why a 483 response isn't successful, resulting in Warning Letter issuance, are that the initial response is later than the deadline or incomplete, or that evidence of implementation and effectiveness of the discussed/promised actions isn't provided when promised or at all.

I also noticed that many companies make corrections but fail to take corrective actions, which is what FDA expects.

 

[sreenu927]

Re: 483 Response Letter - Are there any Special Formal or Content related Requirement

Hi Aphel,

Thank You. Could you also let us know the process after you submit the 483 response?
1. Did you submit any objective evidence(s) with 483 response?
2. Did you provide any periodic reports to FDA?
3. After your 483 response to FDA, did you receive any acknowledgement from them?
4. What was the regulatory decision after your inspection and 483 response - NAI, VAI or OAI?
5. How long it take to receive the EIR after the inspection?

May be, it would be helpful for the team here, if you share the 483 response and of course,taking out your company info and other confidential information!

Regards,
Sreenu