FDA 483 - Panacea Biotec Pharma Limited - October 12, 2023

This FDA Form 483 details nine observations from an inspection of a facility manufacturing sterile injectable drug products, including Injectable Suspension and Injection.

**Observation 1** cites a lack of established, written, and followed procedures to prevent microbiological contamination. Issues include poor aseptic technique during equipment setup (e.g., forceps contacting batch tank, second operator entering LAF area during connection not addressed in studies), operators extending RABs over open vials without discarding, peeling tape used for RAB identification, and unprocedural operator actions to "fix" seals. Personnel monitoring is performed after glove exposure, and forceps for interventions are improperly located.

**Observation 2** notes deficiencies in environmental monitoring. Scientific justification was lacking for moving non-viable particle (NVP) probes away from operator activity and raising them. NVP excursions during equipment assembly are not investigated or assessed unless specific thresholds are met.

**Observation 3** indicates inadequate training for employees performing visual inspection. The visual inspection qualification kit lacked defects like fibers, hair, and cosmetic vial defects. The firm uses a single kit repeatedly for initial and re-qualification, potentially leading to operator familiarity. Inspection fatigue is not addressed during qualification.

**Observation 4** states that procedures to prevent microbiological contamination lack adequate aseptic process validation. Smoke studies are insufficient, failing to demonstrate unidirectional airflow due to improper smoke positioning, camera angles, and unstudied activities like tucking materials above mobile LAF. Media fills are not representative of routine production,