FDA WARNING_LETTER - Apna Foods Imports Co. - November 30, 2021

On November 15 and 30, 2021, the FDA conducted a Foreign Supplier Verification Program (FSVP) inspection of Apna Foods Imports Co. at 360 S. Lombard Rd., Addison, IL. Previous inspections occurred on August 6, 2018, and August 11, 2020. The recent inspection found the company non-compliant with 21 CFR part 1, subpart L, for imported black gram split and semolina from (b)(4), violating section 805 of the FD&C Act. A Form FDA 483a FSVP Observations was issued on November 30, 2021, to which no response has been received.

Significant violations include: 1. Failure to document review and assessment of foreign supplier's hazard analyses for black gram split and semolina, as required by 21 CFR 1.504(d). The provided hazard analyses were unclear regarding hazards requiring control. 2. Failure to approve foreign suppliers based on performance and risk evaluation, and to document this approval, specifically for (b)(4), as required by 21 CFR 1.505(a) and (b). 3. Failure to establish and follow written procedures for approving foreign suppliers, as required by 21 CFR 1.506(a)(1). 4.