FDA 483 - BBS Pharmacy, Inc. dba B&B Pharmacy - August 18, 2015

During an inspection from August 3 to August 18, 2015, the FDA observed multiple deficiencies at the firm.

**Facility and Operations:** The firm manufactures drug products, including sterile injectables like Trimix lot # 08032015@2, BUD 01/30/2016, using ISO 5 hoods and ISO 7/8 clean rooms.

**Violations and Observations:**

* **Microbiological Contamination Prevention (Observation 1):** Procedures to prevent microbiological contamination of sterile drug products were not followed. A technician's hands blocked airflow over vials in an ISO 5 hood during Trimix production. The firm's policy on "Sterile Injectable Recordkeeping Requirements" (Policy # 1751.1) is deficient, lacking media fill frequency requirements. Media fills were performed on an annual basis for ISO 5 hood (b)(4) but not ISO 5 hood #1, despite the latter being used more frequently. * **Environmental Monitoring (Observation 2):** Aseptic processing areas lacked a system for monitoring environmental conditions. No written procedure for non-viable, viable, surface, and personnel monitoring exists. The firm had not formally conducted environmental monitoring, except for a single "for information only" test in November 2014, which yielded a positive result (1 CFU of Chaelomium globosum) from a