FDA 483 - Macleods Pharmaceuticals Limited - August 23, 2024

Macleods Pharmaceuticals Limited, a drug manufacturer in Pithampur, India, was cited for three significant issues during an FDA inspection. Observations included a failure to thoroughly investigate equipment discrepancies, deficient complaint handling procedures for adverse events, and a lack of written procedures and oversight for critical water system alarms. These findings indicate a need for improved quality system controls and adherence to established procedures.