FDA WARNING_LETTER - Mayon's Pharmaceuticals Pvt Ltd - February 20, 2020

On September 4, 2020, the FDA issued a Warning Letter to Mayon’s Pharmaceuticals, Pvt. Ltd. following an inspection from February 17-20, 2020. The inspection revealed significant violations of CGMP regulations for finished pharmaceuticals (21 CFR parts 210 and 211) and deviations from CGMP for active pharmaceutical ingredients (API), rendering their drugs adulterated.

Key violations include: 1. **Finished Drug Violations:** * **Component Testing (21 CFR 211.84(d)(1) and (2)):** Failure to test incoming components for identity, purity, strength, and quality, and lack of supplier qualification. * **Process Control (21 CFR 211.100(a)):** Failure to establish written procedures for production and process control, and releasing drug batches without process validation. * **Equipment Design (21 CFR 211.63):** The water system was not designed to consistently produce water of appropriate quality, with observed dead legs, dripping water, and threaded piping.

2. **API Deviations:** * **Equipment Cleaning:** Failure to clean equipment to prevent contamination, with unidentified debris found in "clean" equipment. * **Cleaning Procedures:** Inadequate written procedures for cleaning equipment and lack of cleaning validation.

The FDA