FDA 483 - Boothwyn Pharmacy LLC - June 16, 2017

The FDA Form 483 documents deficiencies in aseptic processing and quality control at a facility producing sterile drug products.

**Facility and Operations:** The facility produces sterile drug products, including N-Butyl Alcohol 21% Inj, Ascorbic Acid (HCl) 500 mg/mL Inj, Myers Cocktail Inj, Progesterone 150 mg/mL Inj, Calcium Gluconate 1% Inj, Fluorescein 2% Ophthalmic, Gonadotropin (HCG) 5000 u/mL Inj, and Quad-Mix (#3) 30/30/30/1 Inj. Operations involve ISO 5 aseptic processing areas, laminar airflow workstations, and the use of a (b)(4) pump.

**Violations and Observations:** * **Environmental Monitoring (EM) Deficiencies:** EM of the ISO 5 area is not performed daily during sterile drug production. EM sampling is not performed on equipment touched/handled during production, specifically a (b)(4) pump. (b)(4) plates (Lot (b)(4); Exp. 3/29/2017) were used in EM on 5/30/2017. * **Incubation and Testing Issues:** The incubator temperature for media fills, EM surface samples, and (b)(4) samples is not monitored. (b)(4) plates for EM were not