FDA Inspection 1180923 — South Berwick Pharmacy Seacoast Compounding, Inc.
The FDA completed an inspection of South Berwick Pharmacy Seacoast Compounding, Inc. on Sep 30, 2022 in South Berwick, ME. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 4 citations were issued during this inspection. Product area: Veterinary.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Sep 30, 2022
- Fiscal Year
- 2022
- Product Type
- Veterinary
- Project Area
- Monitoring of Marketed Animal Drugs, Feed, and Devices
- Location
- South Berwick, ME (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 18933 | FDCA 501(a)(2)(A) | Vermin, production area |
| 18936 | FDCA 501(a)(2)(A) | Non-microbial contamination, production area |
| 18938 | FDCA 501(a)(2)(A) | Hazardous drugs, prevention of cross-contamination |
| 21377 | FDCA 501(a)(2)(A) | Use of non-pharmaceutical grade components |