FDA Inspection 1221787 — Oxford Pharmaceuticals, LLC
The FDA completed an inspection of Oxford Pharmaceuticals, LLC on November 3, 2023 in Birmingham, AL. 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: Drugs.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- November 3, 2023
- Fiscal Year
- 2024
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Birmingham, AL (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1033 | 21 CFR 211.22(a) | Authority lacking to review records, investigate errors |
| 1213 | 21 CFR 211.67(a) | Cleaning / Sanitizing / Maintenance |
| 1448 | 21 CFR 211.111 | Establishment of time limitations |
| 3603 | 21 CFR 211.160(b) | Scientifically sound laboratory controls |