1218222
ARG Laboratories, Inc. — FEI 3002556034
Inspection Details
- Classification
- Official Action Indicated (OAI) (OAI)
- End Date
- September 20, 2023
- Fiscal Year
- 2023
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Dallas, TX (United States)
Citations
| ID | CFR | Description |
|---|
| 1728 | 21 CFR 211.87 | Retest of approved components/containers/closures |
| 1767 | 21 CFR 211.137(a) | Expiration date lacking |
| 1891 | 21 CFR 211.165(f) | Failing drug products not rejected |
| 3585 | 21 CFR 211.110(a) | Control procedures to monitor and validate performance |
| 3603 | 21 CFR 211.160(b) | Scientifically sound laboratory controls |
| 4314 | 21 CFR 211.84(d)(2) | Reports of Analysis (Components) |
| 9001 | 21 CFR 211.22(a) | Lack of quality control unit |