FDA WARNING_LETTER - KRISHNA TRADING LLC - February 10, 2022

On February 9-10, 2022, the FDA inspected Krishna Trading LLC for Foreign Supplier Verification Program (FSVP) compliance, following previous inspections in November 2018 and June-July 2021. The inspection revealed significant violations of 21 CFR part 1 subpart L and section 805 of the FD&C Act, specifically the failure to develop, maintain, and follow an FSVP for imported foods, including Bhakharwadi, Cumin & black pepper flavored lentil crackers, and Veg Noodles.

The firm received a Form FDA 483a FSVP Observations at each inspection's conclusion. A July 9, 2021, response indicated plans to hire a consultant and collect documents within 15-20 days, but no related documents have been received. No response was received for the February 10, 2022, Form FDA 483a.

The firm stated they did not believe they needed an FSVP as a "very small importer." The FDA clarified that even if eligible for "very small importer" status under 21 CFR 1.500, documentation of this status is required annually, and certain FSVP requirements (21 CFR 1.502, 1.503, 1.509) still apply, along with obtaining written assurances from foreign suppliers.

Failure