FDA WARNING_LETTER - D.K.GROCERY INC DBA APNA BAZAAR CASH AND CARRY - February 27, 2020

The FDA conducted follow-up (February 27, 2020) and initial (August 9, 2018) Foreign Supplier Verification Program (FSVP) inspections of D.K. Grocery Inc. DBA Apna Bazaar Cash and Carry. The inspections revealed the firm is not in compliance with section 805 of the Federal Food, Drug, and Cosmetic Act (FD&C Act) and 21 CFR part 1 subpart L, specifically for imported products like Chick Peas, Moth Whole Polished, and Chana Dal. The primary violation identified is the firm's failure to develop, maintain, and follow an FSVP as required by section 805 of the FD&C Act and 21 CFR 1.502(a). The firm did not respond to the Form FDA 483a observations issued after both inspections. The FDA requires prompt corrective action, including developing and implementing an FSVP. Failure to comply may result in refusal of admission for imported food products under section 801(a)(3) of the FD&C Act, potentially leading to detention without physical examination (DWPE) under Import Alert # 99-41. Importing food without a compliant FSVP is prohibited under section 301(zz) of the FD&C Act. A written response detailing corrective actions and supporting documentation is required within fifteen working days.