FDA Inspection 1100516 — Oxarc, LLC
The FDA completed an inspection of Oxarc, LLC on August 23, 2019 in Coeur D Alene, ID. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 2 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- August 23, 2019
- Fiscal Year
- 2019
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Coeur D Alene, ID (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1133 | 21 CFR 211.25(a) | GMP Training Frequency |
| 1274 | 21 CFR 211.68(a) | Calibration/Inspection/Checking not done |