FDA WARNING_LETTER - Swagath Home Foods LLC - September 18, 2019

The FDA conducted Foreign Supplier Verification Program (FSVP) inspections on February 2, 2018, and September 18, 2019, at 18001 NE 76th St., Ste 120, Redmond, CA 90852, to assess compliance with section 805 of the Federal Food, Drug and Cosmetic Act (FD&C Act) and 21 CFR part 1 subpart L. The inspections revealed significant violations, specifically that the firm did not have FSVPs for imported Black Pepper Powder, Spiced Chutney Powder, and Potato Chips. The firm's response dated September 28, 2019, which included "Swagath Foreign Supplier Verification Program Guidelines," was deemed inadequate. The FDA stated the response failed to demonstrate that the firm had performed any FSVP requirements for particular products and that the guidelines were too general, not reflecting all FSVP rule requirements. The FDA requires prompt corrective action and a written response within fifteen working days, including documentation of revised FSVPs and implementation records. Failure to comply may result in refusal of admission for the affected products under section 801(a)(3) of the FD&C Act, potential detention without physical examination (DWPE) under Import Alert #99-41, and prohibition of importation under section 301(zz) of the FD&C Act.