FDA 483 - Auro Pharmacies, Inc DBA Central Drugs - December 02, 2016

The FDA Form 483 details numerous deficiencies at a facility manufacturing sterile drug products, specifically Ascorbic Acid 500mg/ml.

**Sterilization and Aseptic Processing Deficiencies:** * **Inadequate Sterilization Validation:** Procedures for preventing microbiological contamination lack adequate validation of the sterilization process. * **Process Simulation Issues:** Media fills (process simulations) are inadequate, not representing actual manufacturing operations (e.g., using different media, shorter operational times, smaller batch sizes). Inspection procedures for media fill vials are not described in SOP-SC-01.1365.01. Growth promotion for incubated vials used unknown organism amounts. * **Environmental Control Deficiencies:** No dynamic smoke studies for ISO 5 laminar flow hoods. Aseptic processing areas lack adequate environmental monitoring systems. Room (b)(4) is not qualified to meet ISO 5 and ISO 7 conditions. No justification for environmental monitoring sampling sites, alert/action limits, or non-viable particulate monitoring during filling. Inadequate monitoring of pressure differentials. * **Time Limits and Hold Times:** No established time limits for production phases or hold time studies for (b)(4). * **Personnel Practices:** Inappropriate clothing for personnel. Aseptic fill staff and operators observed with exposed eye areas placing faces directly in/in front of ISO 5 laminar flow hoods during filling and cleaning. Unqualified operators gowned in ISO