FDA WARNING_LETTER - Mentha & Allied Products Private Ltd. - September 25, 2024

The FDA issued a Warning Letter to Mentha & Allied Products Private Ltd. following a September 16-25, 2024, inspection of their Rampur, India facility, identifying significant CGMP deviations for active pharmaceutical ingredients (APIs), rendering their API adulterated. The December 10, 2024, response was deemed inadequate.

Key violations include: 1. **Facility Conditions:** Poor maintenance, soiled washroom, lack of hand soap, dirty gowning room, and visibly soiled cloth gloves for direct product contact without cleaning documentation. 2. **Equipment Cleaning & Maintenance:** Inadequate procedures, "cleaned" equipment found deficient, lack of documented and validated cleaning procedures (e.g., solvent use, critical steps, specific microbial sampling locations), and insufficient cleaning records. 3. **Quality Unit Failures & Data Integrity:** Torn batch records and chromatograms, uncontrolled labeling, non-contemporaneous documentation with backfilling from uncontrolled sheets, and inadequate electronic data controls (e.g., corrupted hard drive for Agilent OpenLab CDS data backup, lack of thorough investigation into data loss). 4. **Material System Deficiencies:** Failure to identity test each batch of incoming raw materials, reliance on unqualified supplier COAs, and lack of supplier qualification for critical raw materials. 5. **Inadequate API Testing & Method Validation:** Failure to test (b)(4) USP (b)(4) API