FDA 483 - Apitoria Pharma Private Limited - October 28, 2019

Aurobindo Pharma Ltd., Unit V, a manufacturer of sterile and non-sterile bulk drugs in Telangana, India, received an FDA Form 483 following an inspection conducted from October 21-28, 2019. The inspection revealed several significant observations related to manufacturing controls and quality systems, indicating potential deviations from current Good Manufacturing Practices. Key issues included deficiencies in laboratory controls, where procedures permitted re-testing of out-of-specification (OOS) API results without scientific justification. The inspection also noted inadequate controls over microorganisms in sterile manufacturing, specifically concerning aseptic filling equipment positioning that could compromise gowning integrity, and protective goggles with unprotected openings. Environmental monitoring in aseptic processing areas was found deficient due to a lack of continuous viable monitoring near exposed stopper packaging materials during critical operations. Furthermore, process validation was incomplete, with unestablished optimal ranges for sealing parameters in packaging processes and for operating parameters in API manufacturing. Additionally, certain equipment lacked sanitization procedures and schedules. Aurobindo Pharma is required to address these observations by implementing comprehensive corrective and preventive actions to ensure compliance with regulatory standards and maintain product quality and safety.