FDA 483 - Boothwyn Pharmacy LLC - August 29, 2023

This FDA Form 483 details observations from an inspection of Boothwyn Pharmacy LLC, a producer of sterile and non-sterile drug products, located at 221 Gale Ln, Kennett Square, PA. The inspection was conducted from August 9 to August 29, 2023. Wayne C. Sartorio, Pharmacist-in-Charge, was the individual to whom the report was issued.

Five observations were noted:

1. **Inadequate Smoke Studies:** Unidirectional airflow was not verified under dynamic operational conditions in ISO 5 classified areas (biological safety cabinet and laminar airflow workbench). Smoke studies from June 2023 did not demonstrate first air movement around equipment, supplies, or operator manipulations. A technician was observed blocking first air and not completing production activities during the production of Alprostadil/Papaverine HCl/Phentolamine Mesylate (Tri-Mix) lot 080920203@L.

2. **Facility Design Flaws:** The facility design allowed lesser quality air into higher quality classified areas. A shared vent between the non-hazardous (ISO 8) and hazardous (ISO 7) drug preparation rooms increased the possibility of cross-contamination, with air potentially flowing from the ISO 8 area into the ISO 7 area and being exhausted through the hood used for hazardous drug production. There was no continuous differential pressure monitoring or real-time alarm in these clean