1214976
Prime Lab LLC — FEI 3017199840
Inspection Details
- Classification
- Official Action Indicated (OAI) (OAI)
- End Date
- August 4, 2023
- Fiscal Year
- 2023
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Ponce, PR (United States)
Citations
| ID | CFR | Description |
|---|
| 1194 | 21 CFR 211.42(c) | Defined areas of adequate size for operations |
| 1213 | 21 CFR 211.67(a) | Cleaning / Sanitizing / Maintenance |
| 1361 | 21 CFR 211.100(a) | Absence of Written Procedures |
| 1767 | 21 CFR 211.137(a) | Expiration date lacking |
| 1842 | 21 CFR 211.84(d)(1) | Component identity verification |
| 1883 | 21 CFR 211.165(a) | Testing and release for distribution |
| 9001 | 21 CFR 211.22(a) | Lack of quality control unit |