FDA 483 - Banner Pharmacy Services, LLC - March 20, 2015

The FDA inspection of an outsourcing facility revealed significant deficiencies in aseptic processing, environmental control, quality systems, and labeling.

**Facility and Operations:** The facility produces sterile drug products in ISO 5 and ISO 7 areas.

**Violations and Observations:**

* **Aseptic Processing Area Deficiencies:** * **Environmental Monitoring:** Lack of active monitoring of differential pressures in ISO 5 areas during production, no devices to read pressure differentials between ISO 5 and ISO 7 areas (separated only by plastic curtains). Lack of routine personnel glove monitoring after daily operations. Insufficient frequency of environmental surface sampling in ISO 5 and ISO 7 areas. No viable particulate air monitoring in the ISO 7 area during aseptic processing. * **Air Supply and HEPA Filters:** No filter leak testing of ISO 5 HEPA filters. Downward trend in HEPA filter air velocities and air exchanges in the ISO 7 area, failing the firm's specification of (b)(4) air exchanges per hour, with no investigation or filter replacement. * **Room Qualification:** Viable air sampling not always dynamic. Non-viable particulate count for ISO 5 areas is an average, not specific to individual HEPA filters. No specification for adjacent HEPA filter air velocities. Smoke studies are static, lack adequate coverage, are not reviewed, and have no final report. * **Airlock/Procedural Controls:** No electronic