FDA 483 - Granules India Limited - September 06, 2024

An FDA Form 483 was issued to the unnamed firm following an inspection conducted from August 21 to September 2, 2024. The central finding outlined a failure to clean manufacturing equipment and utensils at appropriate intervals, compromising drug product safety, identity, strength, quality, and purity, in violation of current Good Manufacturing Practices (cGMP).

Inspectors observed that non-dedicated equipment, including a tablet module, had not been adequately cleaned for years. Visual evidence included significant powdery material accumulation, water, and indications of microbial growth (black and green material) inside Air Purification Units. Chemical analyses of swab samples confirmed cross-contamination, revealing various drug substances exceeding acceptance limits. Unidentified peaks, potentially active ingredients or degradants, were also detected in swab samples.

Further microbial testing of Air Handling Units showed elevated fungal, bacterial, and total viable particulate counts, indicating a high risk of product contamination from the environment. The firm neglected to file all necessary Field Alerts for contaminated batches, especially those with high microbial counts, violating their own Standard Operating Procedures. Moreover, adequate risk and impact assessments for bacterial and fungal contamination of distributed products were not performed. The firm must implement robust cleaning protocols, enhance contamination control, and ensure proper regulatory reporting to safeguard product quality and patient safety.