FDA 483 - Dignity Health - Northridge Hospital Medical Center - November 07, 2017

The FDA Form 483 details multiple deficiencies at a facility producing sterile drugs, including potassium phosphate, potassium chloride, Eribulin mesylate, Azacitidine, and Heparin.

Key observations include: 1. **Facility Design and Air Quality:** The ISO 7 cleanroom, where ISO 5 aseptic processing occurs, uses a plastic strip curtain instead of a permanent door, preventing adequate pressure differential and allowing unclassified air influx. This is a repeat observation from March 2016. 2. **Cleanroom Contamination Sources:** A sink is present in the ISO 7 cleanroom, used by technicians for handwashing before gowning, where sterile drugs are produced. This is a repeat observation. 3. **Classification Discrepancies:** Sterile, hazardous drugs are produced in an ISO 5-classified area located within an unclassified room on the 1st-floor satellite pharmacy. 4. **Structural Integrity:** Unsealed, loose ceiling tiles and visible gaps around recessed sprinkler heads were observed in the ISO 7 cleanroom, impacting the ISO 5 aseptic processing area. 5. **Personnel Flow and Gowning:** No designated anteroom exists; technicians enter the ISO 7 cleanroom in street clothes to don sterile gowns. This is a repeat observation. 6. **Cleaning and Disinfection:** Sporicidal agents were not consistently applied to ISO 5 surfaces. Materials were not disinfected before entering