FDA 483 - Amneal Pharmaceuticals Private Ltd. - December 23, 2022

This FDA Form 483 document details observations from an inspection of a facility manufacturing sterile drug products, specifically focusing on aseptic processing areas.

**Facility and Operations:** The facility operates aseptic fill lines within Restricted Access Barrier Systems (RABS) and utilizes HEPA filters for Grade A areas. Production involves manual activities within these controlled environments.

**Violations and Observations:** * **Aseptic Process Monitoring:** In Process Quality Assurance (IPQA) visual verification of aseptic practices lacks documented rationale for adequacy, and "dos and don'ts" checklists do not delineate Grade A areas. QA does not routinely observe aseptic filling operations on most manufacturing days. * **Personnel Practices:** Production operators access RABS through a small panel, requiring awkward body movements that may compromise aseptic conditions. Goggles worn by operators during aseptic processing were not appropriately fitted, leaving open spaces. * **Disinfectant Qualification:** Disinfectant qualification studies (AP-QCM-MIS-43-00, AP-QCM-MIS-039-00) did not include all cleanroom surfaces/materials (e.g., parts wheels, sealing materials, gowning material). The specific type of disinfectant used in one study was not known. * **Cleaning and Sanitization:** Diffusers assisting HEPA filter air in RABS are not cleaned and sanitized. * **Environmental Monitoring (EM) Program:** * The EM sampling program