Banner Pharmacy Services, LLC – FDA 483, Sep 20, 2017

This FDA Form 483 details numerous deficiencies observed during an inspection of a sterile and non-sterile drug product manufacturing facility.

**Facility and Operations:** The facility compounds sterile drug products like Lidocaine HCl, Oxytocin, Vancomycin, and Total Parenteral Nutrition (TPN), as well as non-sterile oral Vancomycin HCL and GI cocktail oral suspension. The inspection covered ISO 5 laminar hoods, ISO 7 non-hazardous compounding rooms, ISO 8 anterooms (gowning areas), and ISO 8 prep areas.

**Violations and Observations:** * **Quality Control Unit Deficiencies:** The quality control unit lacked authority to reject drug products, specifically releasing batches of sterile drug product that failed potency and particulate matter specifications without adequate justification. * **Stability and Expiration Dates:** Beyond-use dates (BUDs) for sterile drug products were not assigned based on adequate stability testing, with failing stability results disregarded. * **Aseptic Processing Area Deficiencies:** * **Air Filtration:** Leaks were found in HEPA filters in the ISO 7 and ISO 8 cleanrooms during (b)(4) testing in 2016 and 2017. Manufacturing continued for nearly a year without investigation into potential sterility compromise. * **Cleaning and Disinfection:** The firm uses (b)(4) as a sporicidal disinfectant but lacks scientific data to ensure its effectiveness