# FDA 483 - Boothwyn Pharmacy LLC - August 29, 2023

Source: https://www.keypedia.com/records/483/boothwyn-pharmacy-llc/5483a6f8-bbdd-4aca-a063-a239eb3153e6

> FDA 483 for Boothwyn Pharmacy LLC on August 29, 2023. Product: Biologics. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Boothwyn Pharmacy LLC
- Inspection Date: 2023-08-29
- Product Type: Biologics
- Office Name: Philadelphia District Office
- Summary: 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

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## Related Officers

- [Consumer Safety Officer](https://www.keypedia.com/people/christina-k-theodorou/3c18d958-14de-4f25-9fbd-7358205155f7)

Company: https://www.keypedia.com/companies/boothwyn-pharmacy-llc/3ac2c2e2-f194-4c53-9125-a7e1bb4a02c4

Office: https://www.keypedia.com/offices/philadelphia-district-office/c5ec7398-b3d5-4125-9793-fb7b972578d8