1065810
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- September 17, 2018
- Fiscal Year
- 2018
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Pompano Beach, FL (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1215 | 21 CFR 211.67(b) | Written procedures not established/followed |
| 1801 | 21 CFR 211.84(a) | Components withheld from use pending release |
| 1883 | 21 CFR 211.165(a) | Testing and release for distribution |
| 1914 | 21 CFR 211.166(a) | Lack of written stability program |
| 2027 | 21 CFR 211.192 | Investigations of discrepancies, failures |
| 3588 | 21 CFR 211.110(a)(3) | Mixing adequacy |