Akshar Sales LLC – FDA Warning Letter, Apr 28, 2021

On August 16, 2021, the FDA issued a Warning Letter to Akshar Sales, LLC, following Foreign Supplier Verification Program (FSVP) inspections conducted from April 22-28, 2021, and September 7-13, 2018. The inspections aimed to assess compliance with Section 805 of the FD&C Act and 21 CFR Part 1 Subpart L, which mandates risk-based activities for importers to ensure imported food meets U.S. food safety standards.

The FDA found significant violations for imported foods like Chai Biscuits, Fruit Biscuits, and Vermicelli. Key deficiencies include: 1. Failure to document review and assessment of foreign supplier hazard analyses (21 CFR 1.504(d)). 2. Lack of documented evaluation and approval of foreign suppliers (21 CFR 1.505(a) and (b)). 3. Absence of written procedures for approving foreign suppliers (21 CFR 1.506(a)(1)). 4. Failure to determine, perform, and document appropriate foreign supplier verification activities (21 CFR 1.506).

The company did not respond to the Form FDA 483a issued on April 28, 2021. Failure to adequately address these violations may result in refusal of admission for imported food under