Below is an example of what an email looks like coming from the FDA when they are conducting an FSVP Inspection of your facility and your product. Have you received anything like this yet? If so, you're getting ready to be inspected and you need to respond right away to it with the information requested. And if you don't have the FSVP plan written, contact us! We can help you prepare for the inspection.
You were identified at entry for one or more imported foods as the FSVP importer. For purposes of FSVP, importer is defined as: The U.S. owner or consignee of an article of food that is being offered for import into the United States. If there is no U.S. owner or consignee of an article of food at the time of U.S. entry, the importer is the U.S. agent or representative of the foreign owner or consignee at the time of entry, as confirmed in a signed statement of consent to serve as the importer (21 CFR 1.500).
I am contacting you regarding the availability of your FSVP records for FDA inspection for the following products:
- NAME OF PRODUCT manufactured by SHIPPER NAME/ADDRESS imported under entry/line ENTRY LINE NUMBER.
Please respond to this email and provide the following information:
1. Do you maintain your FSVP records onsite?
2. If your FSVP records are located off-site, can you retrieve the records within 24 hours of this request?
3. Are your FSVP records in English?
4. If your FSVP records are in a language other than English, when can you provide an English translation?
5. What is your street address?
6. What is the phone number where I can reach you?
If you believe that you are not the FSVP importer for any food, please respond to this email and explain why you do not meet the definition of FSVP Importer. Please also provide your telephone number in your response.
For additional information on FSVP, please see the following two FSVP fact sheets: Final Rule on Foreign Supplier Verification Programs, and Key Requirements: Final Rule on Foreign Supplier Verification Program.
If you have any questions, please respond to this email or contact me at: XXX-XXX-XXXX ext XXXX.Thank you,
NAME OF OFFICER
Consumer Safety Officer
ORA DIVISION OFFICE
OfficerEmail --- includes .gov in address most likely.