2 replies to this topic

[Ives101]

Hi all

 

Our US distributor received a Warning letter from FDA requesting to provide all records pertaining to Foreign Supplier Verification and to complete the issued form 482d. Has anyone been asked the same and what specific FSVP records does FDA requires?

 

I am requesting you to send FSVP records to FDA, as indicated in the attached Form FDA 482d, Request for FSVP Records. The specific FSVP records that you must send in response to this request are identified in the attached FSVP Records Identification letter. You must promptly send the requested records to FDA as required in section 1.510(b)(3) (21 CFR 1.510(b)(3))of the FSVP regulation.  As required in section 1.510(b)(1) (21 CFR 1.510(b)(1))you must provide, within a reasonable time, an English translation of records that you maintain in a language other than English.  If your FSVP records are in a language other than English, in your response to this email, you should provide us with a timeframe for obtaining an English translation of these records. If you do not have the requested FSVP records, please provide that information in your response to this email.

 

Thanks in advance for replying. 

 

 

[SQFconsultant]

Each forwign supplier must produce their own documents that are in compliance with FSVP.

If your company is the producer than it is your company that must produce the documents.

If your company is supplied by others then it is those suppliers that must generate thw needed doc sets to you and then you provide to your US distributor.

[Kara S.]

Hi all

 

Our US distributor received a Warning letter from FDA requesting to provide all records pertaining to Foreign Supplier Verification and to complete the issued form 482d. Has anyone been asked the same and what specific FSVP records does FDA requires?

 

I am requesting you to send FSVP records to FDA, as indicated in the attached Form FDA 482d, Request for FSVP Records. The specific FSVP records that you must send in response to this request are identified in the attached FSVP Records Identification letter. You must promptly send the requested records to FDA as required in section 1.510(b)(3) (21 CFR 1.510(b)(3))of the FSVP regulation.  As required in section 1.510(b)(1) (21 CFR 1.510(b)(1))you must provide, within a reasonable time, an English translation of records that you maintain in a language other than English.  If your FSVP records are in a language other than English, in your response to this email, you should provide us with a timeframe for obtaining an English translation of these records. If you do not have the requested FSVP records, please provide that information in your response to this email.

 

Thanks in advance for replying. 

 

This is actually a common write up from the FDA this year. Companies that import ingredients or products from foreign entities, such as yourself, need to have a Foreign Supplier Verification Program. They cannot just ask you to send them your FSVP records because you are not the owner of the program you are the foreign supplier they should be verifying. They obviously do not have this program in place at this time. 

 

You should respond back to them, asking which records they require you to provide per their foreign supplier verification program. https://www.ecfr.gov...art-1/subpart-L

Edited by Kara S., 02 November 2022 - 06:18 PM.