Krishiv Foods, LLC – FDA Warning Letter, Dec 13, 2022

On April 25, 2023, the FDA issued a Warning Letter to Krishiv Foods, LLC, following a Foreign Supplier Verification Program (FSVP) inspection conducted from November 30 to December 13, 2022, with previous inspections on July 28, 2022, and May 4-14, 2021. The inspection found the company non-compliant with section 805 of the FD&C Act and 21 CFR part 1, subpart L, for imported whole nutmeg, moong dal, and whole mustard seed from a foreign supplier in (b)(4).

Key violations include: 1. Failure to document review and assessment of the foreign supplier's hazard analyses for whole nutmeg, moong dal, and whole mustard seeds, as required by 21 CFR 1.504(d). 2. Failure to document evaluation of the foreign supplier's performance and risk, and approval of the foreign supplier, as required by 21 CFR 1.505(a)(2) and 1.505(b). 3. Failure to conduct or obtain documentation of required supplier verification activities for the imported foods before and periodically after importation, as required by 21 CFR 1.506(e). Specifically, documentation for moong dal and whole mustard seeds was missing, and