FDA WARNING_LETTER - Dilip Ceramics Inc. dba Shivam Distributors - January 06, 2021

On May 4, 2021, the FDA issued a Warning Letter to Nirmal V. Panchal following a Foreign Supplier Verification Program (FSVP) inspection conducted from December 29, 2020, to January 6, 2021. The inspection, which reviewed electronically submitted FSVP records, found the company non-compliant with section 805 of the Federal Food, Drug, and Cosmetic Act (FD&C Act) and 21 CFR part 1 subpart L.

Significant violations include: 1. Failure to develop, maintain, and follow an FSVP for Cumin Powder imported from foreign supplier (b)(4), as required by 21 CFR 1.502(a). 2. For Red Lentils from (b)(4) and (b)(4) Basmati Rice from (b)(4), the company failed to conduct a hazard analysis (21 CFR 1.504), evaluate foreign supplier performance (21 CFR 1.505), or perform foreign supplier verification activities (21 CFR 1.506). Specifically, no written hazard analysis was provided, no documentation of supplier performance evaluation or approval was submitted, and no written procedures for verification activities were established. The provided third-party audit certificate and quality assurance certificate were deemed insufficient without documented review or explanation of their relation to the FSVP.

The company did