FDA 483 - Essential Pharmacy Compounding - May 22, 2015

The FDA inspected Essential Pharmacy Compounding, a producer of sterile human and veterinary drug products, from May 12-22, 2015, and issued a Form 483 with 12 observations.

**Key Violations and Observations:**

1. **Inadequate Sterilization Process Validation:** * Smoke studies for static airflow lacked documented management evaluation; dynamic studies were undocumented. * An operator was observed not following sterile drug production procedures in an ISO 5 hood, including resting arms on surfaces. * Media fills for sterile injectable drugs were not performed under representative worst-case aseptic processing conditions. * Primary sterilization steps (redacted) lacked challenge to establish upper bio-burden limits; incoming non-sterile APIs and formulated products were not evaluated for bio-burden.

2. **Inappropriate Personnel Clothing:** * Employees had exposed eyes and foreheads in the ISO 5 cleanroom. * An employee cleaning an ISO 5 hood placed exposed forehead/eyes and upper body inside it. * Sterile gowns were reused after exiting and returning to sterile production areas.

3. **Deficient Environmental Monitoring:** * Environmental monitoring (viable, non-viable, personnel) was not conducted daily during production, despite production occurring frequently. * Pressure differentials between the "Buffer room" (ISO 5) and "Ante Room