857033
Cross Brands Contract Filling, LLC — FEI 1000525249
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- November 8, 2013
- Fiscal Year
- 2014
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- West Melbourne, FL (United States)
Citations
| ID | CFR | Description |
|---|
| 1098 | 21 CFR 211.22(c) | Approve or reject procedures or specs |
| 1112 | 21 CFR 211.25(a) | Training--operations, GMPs, written procedures |
| 1215 | 21 CFR 211.67(b) | Written procedures not established/followed |
| 1890 | 21 CFR 211.165(e) | Test methods |
| 1891 | 21 CFR 211.165(f) | Failing drug products not rejected |
| 2027 | 21 CFR 211.192 | Investigations of discrepancies, failures |
| 2567 | 21 CFR 211.198(a) | Adverse Drug Experience |
| 3603 | 21 CFR 211.160(b) | Scientifically sound laboratory controls |
| 4314 | 21 CFR 211.84(d)(2) | Reports of Analysis (Components) |
| 4402 | 21 CFR 211.192 | Written record of investigation incomplete |