FDA WARNING_LETTER - STC India Private Limited - January 17, 2023

On July 21, 2023, the FDA issued Warning Letter #661775 to Mr. Shah of #201, 2nd Floor, Jyoti Industrial Estate, Shakti Nagar, C.S. Road Dasihar-East Mumbai 400068 Maharashtra India, following an inspection from January 12-17, 2023. The inspection focused on ready-to-eat (RTE) mouth fresheners (mukhwas).

The FDA found serious violations of the Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Human Food regulation (21 CFR Part 117), deeming the RTE mukhwas adulterated under section 402(a)(4) of the Federal Food, Drug, and Cosmetic Act (the Act) due to insanitary conditions.

Key violations include: 1. **Hazard Analysis Deficiencies (21 CFR Part 117, Subpart C):** The hazard analysis for RTE mukhwas (dated May 10, 2022) failed to identify and evaluate bacterial pathogens like Salmonella as a known or reasonably foreseeable hazard, despite ingredients like seeds and spices being associated with Salmonella. No process preventive control (e.g., lethal treatment) or supply-chain program (e.g., annual onsite audits for high-risk ingredients) was identified or implemented to control this hazard.