Kings Park Slope Inc – FDA 483, Apr 22, 2016

The FDA Form 483 details multiple deficiencies at an outsourcing facility.

**Environmental Monitoring & Aseptic Processing:** * **Pressure Differential Loss:** The ISO 7 cleanroom and ISO 8 anteroom experienced multiple positive pressure differential losses between December 2015 and January 2016. Continuous monitoring was absent, making it unknown if losses occurred during sterile processing. * **Viable Air Sampling:** Passive viable air sampling using settling plates was not conducted during compounding operations (e.g., Glycopyrrolate 0.6 mg/3 mL, Lot #G0406116, on 4/5/2016), contrary to SOP 03-18.01. The firm stated this is performed only by an outside contractor. * **Personnel Monitoring:** Personnel monitoring was not conducted after each compounding session, including for a Glycopyrrolate production on 4/5/2016 that lasted over an hour. * **Sterilization Validation:** Media fill simulation was not performed for all aseptic processing. * **Gowning Procedure:** SOP 05-04.01 regarding protective eyewear (goggles) was not adequately followed, and sterility maintenance during de-gowning was not assured. * **Unidirectional Airflow:** Adequate unidirectional airflow studies under dynamic conditions were not performed. * **Sterilization Uniformity