679072
Rasi Laboratories, Inc. — FEI 2245465
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- September 3, 2010
- Fiscal Year
- 2010
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Cranbury, NJ (United States)
Citations
| ID | CFR | Description |
|---|
| 1112 | 21 CFR 211.25(a) | Training--operations, GMPs, written procedures |
| 15494 | 21 CFR 111.25(c) | Procedures - equipment - cleaning, sanitizing |
| 15642 | 21 CFR 111.455(a) | Hold - temperature, humidity, light |
| 15675 | 21 CFR 111.315(b) | Sampling plans; establish, follow |
| 15853 | 21 CFR 111.73 | Specifications met - identity, purity, strength, composition |
| 15930 | 21 CFR 111.105 | Quality control - ensure quality; package, labeled, master record |
| 1833 | 21 CFR 211.84(d)(1) | Identity Testing of Each Component |
| 2027 | 21 CFR 211.192 | Investigations of discrepancies, failures |
| 2031 | 21 CFR 211.194(a) | Complete test data included in records |
| 4389 | 21 CFR 211.198(a) | Procedures to be written and followed |