FDA Inspection 866595 — Crown Laboratories
The FDA completed an inspection of Crown Laboratories on February 14, 2014 in Johnson City, TN. The inspection was classified OAI (Official Action Indicated — objectionable conditions were found and regulatory action is recommended). 6 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Official Action Indicated (OAI) (OAI)
- End Date
- February 14, 2014
- Fiscal Year
- 2014
- Product Type
- Drugs
- Project Area
- Unapproved and Misbranded Drugs
- Location
- Johnson City, TN (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1274 | 21 CFR 211.68(a) | Calibration/Inspection/Checking not done |
| 1626 | 21 CFR 211.130 | Procedures are written, and followed |
| 1809 | 21 CFR 211.160(a) | Following/documenting laboratory controls |
| 1890 | 21 CFR 211.165(e) | Test methods |
| 1912 | 21 CFR 211.166(a) | Written program not followed |
| 4325 | 21 CFR 211.110(a) | Control procedures fail to include the following |