FDA 483 - Eugia Pharma Specialities Limited - February 02, 2024

The FDA Form 483 details significant violations at a manufacturing facility producing sterile injectable products for the US and Canadian markets.

**Observation 1: Microbiological Contamination Prevention** Procedures to prevent microbiological contamination during aseptic filling were not followed. Operators failed to sanitize hands, leaned over open vials, used unsanitized tools, and directly touched sterile parts. Interventions were not documented, evaluated in smoke studies or media fills, or had personnel monitoring. Glass breakage occurred without removing surrounding vials or documentation. RABS were extended over open vials and sterile components without removal or proper sanitization. Cleaning of Grade A equipment and surfaces was not performed as documented, with personnel confirming they falsified cleaning records.

**Observation 2: Incomplete Laboratory Records** Laboratory records lacked complete data. Integrity testing of components was not performed on all required units, despite passing results being generated. Production personnel admitted to repeatedly testing the same units and assigning IDs from untested units, stating some units would not pass. Environmental monitoring samples for Grade A surfaces and non-viable particle counts (NVPC) were documented as collected but were never taken from the specified locations, with personnel confirming samples were taken from other areas and instrument times/dates were altered. Air sampling was also not performed at documented locations. CCTV footage showed Grade A RABS surface monitoring was performed without the sampling device touching the media plate.

**Observation 3: Incomplete Batch Production and Control Records** Batch records were incomplete. Cleaning of