FDA WARNING_LETTER - Aman Kapoor In - December 17, 2020

On March 10, 2021, the FDA issued a Warning Letter to Aman Kapoor, Inc. following a remote Foreign Supplier Verification Program (FSVP) inspection conducted from December 1-17, 2020, and a previous inspection on September 13, 2017. The inspections aimed to assess compliance with section 805 of the FD&C Act and 21 CFR part 1 subpart L.

The firm was found non-compliant for imported Cornflakes Mixture, Cashew Mixture, and Dried Vegetable Soup Mix, specifically failing to develop, maintain, and follow an FSVP as required by 21 CFR 1.502(a). Despite providing some documents from foreign suppliers during the inspection, these did not correspond to the products in question, nor did the firm explain their relevance to an FSVP. No FDA 483 response was received.

Additionally, the firm failed to conduct or properly document review and assessment of hazard analyses for imported foods, as required by 21 CFR 1.504(a) and (d). Hazard analyses for Cornflake Mixture and Cashew Mixture were not submitted, and documentation for Dried Vegetable Soup Mix was absent. For other products, documentation of review and assessment of foreign supplier hazard analyses, or confirmation that they were conducted by a qualified individual, was not provided.

Failure to address these violations may result in refusal of admission for