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Briarcliff767
Briarcliff767, FDA-expert
Category: General
Satisfied Customers: 3643
Experience:  Research and Records
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I wish to file an FDA annual report according to regulation

Customer Question

I wish to file an FDA annual report according to regulation 21CFR1002.13, section 1002.13 Annual reports.
I am very late, as the deadline has passed on September 1 of this year.
How may I submit my report?
Submitted: 1 year ago.
Category: FDA
Expert:  Briarcliff767 replied 1 year ago.

Hi, My name is ***** ***** I am happy to assist you. You should have received a warning letter in the mail. If you did not receive this warning letter you need to call (1-***-***-****) to request what steps you have to take in order to not be help in legal obligation from not reporting to the FDA your yearly standing. Please let me know if you need further help and if you received the warning letter also let me know there should have been in the letter the steps that you will need to take in order to get the report in.

Hope

Customer: replied 1 year ago.

We did not receive a letter.

Now, I need to identify which annual report form that is needed.

Expert:  Briarcliff767 replied 1 year ago.

Hi yes then the only way that you will be able to get your account back in standings with the annual reports is to call (1-***-***-****) to request what steps you have to take in order to not be help in legal obligation from not reporting to the FDA your yearly standing

Expert:  Briarcliff767 replied 1 year ago.

You will have to provide your company information. That in which should not be put here on the internet but through the FDA phone number above

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