- FDA recently posted two warning letters issued to companies for failure to comply with the foreign supplier verification program (FSVP) requirements in Section 805 of the Federal Food, Drug, and Cosmetic Act (21 USC 384a) and the implementing regulations in 21 CFR part 1, subpart L. FSVP is intended to verify that food imported into the U.S. is produced consistent with food safety standards that provide at least the same level of protection as the food safety standards that would apply to the food if it were produced in the U.S.
- In one letter to Garcia Fresh Vegetables LLC, FDA indicated that the company had not developed an FSVP for any of the foods that it imports, including fresh produce. In another letter to Radhaswamy Inc. dba Raja Foods LLC, FDA stated that the company had failed to develop an FSVP for all but one of its products and had further failed to take any corrective actions following importation of a product that was added to an import alert due to pesticide adulteration.
- Both warnings letters were issued after multiple inspections and following failures to respond to FDA 483a forms issued at the end of the inspections. FSVP violations continue to be a significant source of warning letters.
FDA Issues FSVP-Related Warning Letters
Sunday, March 9, 2025
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