FDA WARNING_LETTER - Subhlaxmi Grocers - January 18, 2022

The FDA conducted a Foreign Supplier Verification Program (FSVP) inspection of Subhlaxmi Grocers from December 2021 to January 2022, following a previous inspection in April 2019. The inspection revealed significant violations of section 805 of the Federal Food, Drug, and Cosmetic Act (FD&C Act) and 21 CFR part 1, subpart L, pertaining to various imported foods including potato wafer jali, cumin coriander mix powder, and turmeric powder. The firm failed to develop, maintain, and follow an FSVP as required by 21 CFR 1.502(a). Specifically, for certain imported products, Subhlaxmi Grocers did not conduct a hazard analysis or properly document the review and assessment of foreign suppliers' hazard analyses by a qualified individual, violating 21 CFR 1.504 and 1.504(d). Furthermore, the firm failed to evaluate foreign suppliers' performance and the risk posed by these foods, as mandated by 21 CFR 1.505 and 1.505(d). Lastly, the firm did not perform foreign supplier verification activities in accordance with 21 CFR 1.506, failing to determine and document verification activities and frequencies, and not conducting or documenting required activities. The FDA noted no response to the issued Form FDA 483a. Subhlaxmi Grocers must respond within fifteen working days with corrective actions and supporting documentation. Failure to comply may result in refusal of admission of imported foods, detention without physical examination (DWPE), and prohibition of importation under sections 801(a)(3) and 301(zz) of the FD&C Act.