FDA WARNING_LETTER - 2m Associates, Inc. - March 03, 2021

The FDA conducted a remote Foreign Supplier Verification Program (FSVP) inspection of 2m Associates Inc. from February 1 to March 3, 2021, following an initial inspection in April 2019. The inspection aimed 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 firm was found not in compliance for its imported (b)(4) broken rice and (b)(4) rice from (b)(4). Specifically, 2m Associates Inc. failed to develop, maintain, and follow an FSVP as required by section 805 of the FD&C Act and 21 CFR 1.502(a). As of the warning letter date, no response to the Form FDA 483a issued on March 3, 2021, had been received. The FDA requires a written response within fifteen working days detailing corrective actions, including documentation of changes and implementation records. Failure to adequately address these violations may result in refusal of admission for the imported rice, detention without physical examination (DWPE) under Import Alert # 99-41, and prohibition of importation under section 301(zz) of the FD&C Act.