FDA 483 - Eugia Pharma Specialities Limited - December 14, 2018

The FDA Form 483 details significant violations at a pharmaceutical facility, primarily concerning the prevention of microbiological contamination in sterile drug products.

**Observation 1** highlights failures in establishing and following procedures to prevent microbiological contamination. This includes: * **Inadequate Environmental Monitoring:** Air sampling procedures are insufficient, with samples not representative of air quality over the entire filling duration. Specific deficiencies include no dynamic air samples near vial stoppering stations, misplaced or non-functional settling plates, and lack of dynamic air or surface samples in critical areas like stopper handling and syringe filling/stoppering. Non-viable particulate (NVP) monitoring is not continuous in several Grade-A areas with continuous operator activity. * **Deficient Smoke Studies:** Video recordings of smoke studies for filling-line assembly and aseptic filling activities are incomplete or unrepresentative. They fail to show airflow patterns during critical transfers of sterile components from mobile LAF carts to filling line enclosures, expose components to Grade-B conditions without sanitization, and do not accurately simulate operator interventions or potential airflow blockages. * **Unrepresentative Media-Fill Interventions:** Media-fill runs do not accurately represent routine aseptic filling interventions in terms of frequency and duration. Intervention records lack detail on execution points, duration of operator passages, and specifics of simulated mechanical interventions, making it impossible to assure the aseptic environment is adequately challenged. * **Improper Component Handling:** Procedures lack instructions for sanitizing the outer surface of equipment