Buffalo Pharmacies Inc – FDA 483, Jun 23, 2017

An FDA Form 483 was issued following an inspection of a drug product compounding facility. The inspection revealed several deficiencies related to aseptic processing and environmental controls.

**Violations and Observations:**

1. **Inadequate Gowning Procedures:** The firm lacked a gowning procedure and aseptic processes to prevent contamination. A compounding technician was observed reusing a gowning jacket between multiple product preparations daily. The technician also donned gloves inside the ISO 5 laminar flow hood, exposing skin. Unfiltered air was introduced into a sterile bottle of Tacrolimus wet product via a syringe to create positive pressure. 2. **Lack of Media Fills:** Procedures to prevent microbiological contamination were not established or followed, as the firm had not performed media fills to simulate aseptic production operations, including worst-case activities and conditions. 3. **Deficient Cleaning and Disinfection:** * Non-sterile wipes were used for sanitization of ISO 5 laminar flow hood surfaces. * Sporicidal agents were not used in the cleanroom and ISO 5 area; non-sterile disinfectants were used instead. 4. **Inadequate Environmental Monitoring:** * Viable and non-viable monitoring of ISO 5 and ISO 7 areas was not conducted during dynamic processes. The firm lacked equipment for this testing and did not use an outside contractor. Only non-viable monitoring was performed under static conditions. * Smoke studies were not performed under