FDA Releases List of Importer Records Required by FSVP Regulations
The Food and Drug Administration on Oct. 7 announced it has created a new list of records required by the Foreign Supplier Verification Program regulations. The list Is intended to “help importers determine the FSVP records they should develop and…
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maintain,” FDA said in an emailed announcement. “During an FSVP inspection, the FDA investigator will review the importer’s records to determine their compliance with the FSVP regulation,” FDA said. The list is organized based on the sections of the FSVP regulations “so that importers can readily determine the required records for the sections that apply to them,” the agency said. “Importers should note that not every record on the list will be applicable to them, so they will need to determine whether they are subject to an exemption, standard FSVP requirements, or modified FSVP requirements.”