FDA 483 - InfuScience a subsidiary of Bioscrip - May 15, 2015

This FDA Form 483 details significant deficiencies observed during an inspection of a facility producing sterile injectable drug products, including hydromorphone, penicillin-type, and beta-lactam non-penicillin drugs.

**Key Violations and Observations:**

* **Complaint Handling:** The firm failed to follow procedures (CLIN-PH107, ADMP015) for reporting an adverse event related to hydromorphone on 11/24/14 to the Corporate Clinical Services Department, despite noting it in an electronic chart and sending a replacement. * **Personnel Gowning:** Cleanroom operators performing aseptic manipulations wore non-sterile gowns, caps, and face masks. Non-sterile eye protection did not fully cover the area around the eyes, leaving exposed facial skin over critical ISO 5 laminar flow areas. * **Environmental Monitoring:** Viable and non-viable air counts in ISO 5 zones were not performed daily during production, only during annual cleanroom certification. Work surfaces and operator gloves in ISO 5 hoods were not tested daily for microbial contamination. ISO 7 clean rooms and anterooms lacked continuous air pressure differential monitoring, with one gauge showing approximately zero inches W.G. on 05/12/15. * **Cleaning and Disinfection:** Non-sterile, particle-shedding wipes were used to disinfect ISO 5 hoods. Sporicidal agents were not used, and a