FDA WARNING_LETTER - Granules India Limited - September 06, 2024

On February 26, 2025, the FDA issued a Warning Letter to Granules India Limited following an inspection from August 26 to September 6, 2024. The inspection revealed significant violations of Current Good Manufacturing Practice (CGMP) regulations for finished pharmaceuticals, rendering their drug products adulterated.

Key violations include: 1. **Inadequate Cleaning and Maintenance of Equipment (21 CFR 211.67(b))**: Significant contamination, including residues from multiple drug products and microbial contamination, was found in non-dedicated air handling unit (AHU) ducts. The firm lacked documented cleaning procedures for certain duct sections, and their response, including retrospective MACO calculations and limited reserve sample testing, was deemed inadequate as it did not fully address the cross-contamination risk. 2. **Failure to Maintain Buildings (21 CFR 211.58)**: Bird droppings and feathers were observed in the AHU area, indicating poor facility repair and potential contamination of air supplied to manufacturing equipment. The firm's response, while addressing bird entry, lacked a thorough root cause analysis and failed to assess similar vulnerabilities or ensure complete exclusion of pests. 3. **Failure to Calibrate and Maintain Equipment (21 CFR 211.68(a))**: The firm failed to adequately inspect and maintain AHUs, specifically regarding HEPA filter integrity and particle count testing. The quality unit