Foreign Suppliers Recently Mistakenly Added to FSVP Import Alert, FDA Says

The FDA mistakenly added three foreign companies to Import Alert 99-41 recently for violations of Foreign Supplier Verification Program requirements, an agency spokesperson said. The additions were in error, and the agency is “taking steps to ensure future listings adhere to the intent of the import alert, which is to address an importer’s lack of compliance with the FSVP regulation,” the spokesperson said by email on Oct. 21.

The foreign companies -- two French and one Indian -- had been added alongside two importers that were added to the import alert on Oct. 7 and Oct. 20. The foreign companies were removed from the import alert on Oct. 21.

Import Alert 99-41 says specific food or foods from “a specific foreign supplier may be included on the Red List to identify the food or foods that are subject to [Detention Without Physical Examination (DWPE)] when imported or offered for import by the identified importer.” Contrary to that guidance, neither of the listings for the foreign companies listed an importer, and the two French companies were listed for all foods. The three foreign companies were the first suppliers that had been added to the import alert, and after removal the import alert again only lists U.S.-based importers.

The foreign companies had presumably been added in connection with the listing of two U.S. importers. The same day that it listed the two French companies, FDA on Oct. 20 added California-based importer Gourmet & More to the import alert, following a warning letter it sent to the company in July citing a lack of FSVP documents for two types of imported cheese. The warning letter said Gourmet & More sent some documentation on its FSVPs for the two cheeses to the FDA, but the agency was unable to evaluate it because the documents had not been translated into English. Gourmet & More also “did not provide details as to how the documents meet the requirement of the FSVP regulation,” the FDA said.

Previously, on Oct. 7, the FDA had the Indian exporter as its first foreign supplier on Import Alert 99-41. On the same day, the agency added the New York-based importer Maspeth Wholesale (which also does business as Apna Wholesale) to the import alert for its lack of an FSVP. A warning letter sent to Maspeth in May also cited it for a lack of an FSVP for its imported food.

FDA has continued to issue warning letters for FSVP violations at a brisk pace over the summer and into the fall. The agency sent five in June and six in July, though it sent only two in August. FDA has so far uploaded to its website three sent in September and one sent in October. There is generally a delay between when a warning letter is sent and when one is uploaded, so the agency may have sent more in those two months.

FDA uploaded its latest two FSVP warning letters Oct. 20. One, sent Oct. 7 to Aspen Sales Group, says the importer did not maintain FSVPs for its refined sugar and frozen French fries, and failed to meet related documentation requirements. The other, sent Sept. 24 to V-Nine, says it did not have an FSVP for its imported pad Thai sauce.