FDA 483 - BioScrip Pharmacy (NY), Inc. - September 19, 2014

The FDA Form 483 details significant deficiencies in aseptic processing, environmental control, and quality systems at a drug product manufacturing facility.

**Aseptic Processing Deficiencies:** * **Airflow and Pressure:** Smoke studies were not performed dynamically in ISO 7 clean rooms to verify unidirectional airflow in ISO 5 hoods/biological safety cabinet. Air pressure differentials in ISO 7 clean rooms, anteroom, and surrounding areas are not continuously monitored. A semi-annual certification on 1/06/14 showed the non-hazardous (IV mix room) differential pressure at -0.007, below the 0.02-0.05 limit, with no investigation. * **Operator Practices:** An operator placed non-sterile glove outer wrapping and a non-sterile cloth wipe onto an ISO 5 working surface during sterile drug processing. * **Personnel Gowning:** Operators wore non-sterile gowns, glasses/goggles, footwear, facial masks, and bonnets. Their faces and necks were not fully covered, exposing skin and hair over critical ISO 5 laminar flow areas.

**Environmental Monitoring Deficiencies:** * **Viable Air Counts:** Not performed daily in ISO 5 zones; only semi-annually (last on 7/01/14). * **Non-Viable Particulates:** Not performed under dynamic conditions in ISO 5 zones (last on 7/