FDA Inspection 1217606 — Boothwyn Pharmacy LLC
The FDA completed an inspection of Boothwyn Pharmacy LLC on August 29, 2023 in Kennett Square, PA. The inspection was classified OAI (Official Action Indicated — objectionable conditions were found and regulatory action is recommended). 5 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Official Action Indicated (OAI) (OAI)
- End Date
- August 29, 2023
- Fiscal Year
- 2023
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Kennett Square, PA (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 22733 | FDCA 501(a)(2)(A) | Beta-lactam, hazardous, highly potent drugs, prevention of cross-contamination |
| 22751 | FDCA 501(a)(2)(A) | Facility design, influx of lesser quality air |
| 22758 | FDCA 501(a)(2)(A) | Non-sterile disinfecting agents, ISO 5 area/classified areas |
| 22759 | FDCA 501(a)(2)(A) | Sporicidal agent, ISO 5/classified areas |
| 22766 | FDCA 501(a)(2)(A) | Inadequate smoke studies |