FDA 483 - Cipla Limited - June 21, 2024

Cipla Limited, a drug manufacturer in Verna, India, received a Form 483 with six observations during an FDA inspection from June 10-21, 2024. The observations highlight significant deficiencies in test method validation, environmental monitoring for aseptic processing, cleaning and disinfection procedures, and investigation of batch failures. Additionally, issues were noted with computer system access controls and adherence to quality control unit procedures.