FDA Inspection 1263751 — Libby Laboratories, Inc.
The FDA completed an inspection of Libby Laboratories, Inc. on March 14, 2025 in Berkeley, CA. The inspection was classified OAI (Official Action Indicated — objectionable conditions were found and regulatory action is recommended). 2 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Official Action Indicated (OAI) (OAI)
- End Date
- March 14, 2025
- Fiscal Year
- 2025
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Berkeley, CA (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1801 | 21 CFR 211.84(a) | Components withheld from use pending release |
| 1885 | 21 CFR 211.165(b) | Microbiological testing |