FDA WARNING_LETTER - North30 LLC - April 08, 2022

The FDA issued a Warning Letter to North30 LLC following a Foreign Supplier Verification Program (FSVP) inspection conducted from March 14 through April 8, 2022, with a prior inspection in 2020. The inspection revealed the firm is not in compliance with section 805 of the Federal Food, Drug, and Cosmetic Act (FD&C Act) and the implementing FSVP regulation in 21 CFR part 1, subpart L. The significant violation identified was the failure to develop, maintain, and follow an FSVP for any of the foods imported, as required by 21 CFR 1.502(a). The firm did not respond to the Form FDA 483a issued on April 8, 2022, and continued importing food after the inspection. North30 LLC must respond in writing within fifteen working days, detailing specific corrective actions, including documentation of an implemented FSVP. Failure to adequately address these violations may result in refusal of admission for imported foods under section 801(a)(3) of the FD&C Act, potential detention without physical examination (DWPE) under Import Alert #99-41, and is prohibited under section 301(zz) of the FD&C Act.