Importers of human and animal food must ensure that their foreign suppliers put in place controls that prevent biological, chemical, and physical hazards. Under the Foreign Supplier Verification Program or FSVP, FDA tries to ensure that food produced outside the United States meet the same safety standards as those manufactured domestically. To give readers a sense of what FDA is looking for during an inspection, we have provided a summary of three warning letters issued since February 2024 for FSVP violations.
CASE STUDY #1: Company A
FDA initiated an inspection when a lab inspector found that a sample of fresh enoki mushrooms contained Listeria monocytogenes. FDA conducted the inspection between late February 2024 and early March 2024. They found that the importer (Company A) did not “develop, maintain, and follow an FSVP” for the following foods:
- Fresh Enoki Mushrooms
- Fresh Seafood Mushrooms
- Fresh Bamboo Shoots
In addition, the FDA determined that Company A failed to register their domestic food facility with FDA. The FDA inspector gave the company 30-days to register their food facility. The FDA also mandated that the importer implement an FSVP for all foreign suppliers. Company A must respond in writing within 15 days for how they will specifically address each of these violations. If necessary, the importer should discontinue use of foreign supplier(s) until safety standards are met. If corrective actions are not met, FDA may place Company A’s imports on detention without physical examination (DWPE).
CASE STUDY #2: Company B
FDA conducted an inspection in early February 2024 of a California based importer (Company B). FDA found that Company B’s foreign suppliers did not comply with the Produce Safety Rule (PSR). The foods which violated the PSR were:
- Seafood mushrooms
- Oyster mushrooms
- Taiwanese Mangos
Though an FSVP was established for these foods, extra PSR standards for “growing, harvesting, packing, and holding of produce for human consumption” must be in place for these fruits and vegetables. The importer did not evaluate the foreign supplier’s performance and the risks posed by these foods.
FDA also noted that FSVP documents did not identify the foreign supplier (they identified that a foreign entity “sold” and “packed” the food, but the FSVP never actually identified the manufacturer). Additionally, FDA noted that the third part audit did not consider biological controls for the oyster and seafood mushrooms. If Company B does not address the violations, FDA may refuse admissions of food the company imports and could place these foods on detention without physical examination (DWPE).
CASE STUDY #3: Company C
Between early and late March 2024, FDA conducted an FSVP inspection for Company C. An earlier inspection was also conducted in mid-June 2021. The FDA found that Company C did not implement an FSVP for any food they import. No FSVP was developed for:
- Broad beans
- Crushed chili
- Nut snacks
- Dehydrated mango, half slices
As a result of these violations, FDA could refuse admissions of any product Company C imports. They could also place any food imported into the US on detention without physical examination (DWPE).
Concluding Remarks
Based on the above summary of recent warning letters, we see how FDA conducts a comprehensive inspection of records and responds to an FSVP violation. Obviously, FDA will notice when no FSVP is in place. However, we also see FDA analyzing in place FSVP records, rejecting the importers claims and demanding stricter enforcement of the Product Safety Rule. FDA clearly requires companies to practice vigilance when creating an FSVP for each product they import.
Here at Ken Lehat & Associates, we are here to help you create an FSVP for each product you import. We can also help you manage records and prepare for an FDA investigation. We have many years helping importers work with FDA. For more information, please contact us:
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