FDA 483 - Randol Mill Pharmacy - August 06, 2019

During an inspection from July 23 to August 6, 2019, Randol Mill Pharmacy, a producer of sterile and non-sterile drug products located at 1014 N Fielder Rd, Arlington, TX, received a Form FDA 483 with seven observations.

Key violations include: 1. **Aseptic Processing Deficiencies:** A pharmacy technician's eyebrows were exposed in the ISO 5 LAF hood during aseptic processing of Progesterone Cottonseed Oil 100 mg/ml injectable. 2. **Non-Sterilized Equipment Use:** Non-sterilized syringes, a (b)(4) and metal cap crimper were used in the ISO 5 LAF hood. The technician also failed to disinfect two syringes and re-sanitize hands after re-entering the ISO 5 area multiple times. The firm's sporicidal agent, (b)(4) Solution, was found inadequate for the aseptic processing area. 3. **Facility Design Flaws:** The cleanroom design allowed poor-quality air into the ISO 7 area. A portable A/C unit feeding the ISO 7 cleanroom (where the ISO 5 LAF is located) lacked maintenance records and air quality assessment. Wall-mounted HEPA filters in ISO 8 and ISO 7 areas were not assessed for adequate airflow, and airflow vents were obstructed. 4. **Cross-Contamination Risk:**