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Talk to a SpecialistTalk to a SpecialistSTC India Private Limited, a food manufacturer in Mumbai, produced ready-to-eat mouth fresheners (mukhwas) found to be adulterated because they were prepared, packed, or held under insanitary conditions that could have resulted in contamination with filth or rendered them injurious to health. The January 2023 FDA inspection identified serious violations of Current Good Manufacturing Practice (CGMP) and Hazard Analysis and Risk-Based Preventive Controls requirements under 21 CFR Part 117. The company submitted a response in February 2023 with corrective actions, revised food safety plans, and supporting documentation, but the violations represented failure to comply with mandatory preventive controls provisions for covered food facilities.