936055
Frontida BioPharm Inc — FEI 2523348
Inspection Details
- Classification
- Official Action Indicated (OAI) (OAI)
- End Date
- July 17, 2015
- Fiscal Year
- 2015
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Philadelphia, PA (United States)
Citations
| ID | CFR | Description |
|---|
| 1105 | 21 CFR 211.22(d) | Procedures not in writing, fully followed |
| 1215 | 21 CFR 211.67(b) | Written procedures not established/followed |
| 1361 | 21 CFR 211.100(a) | Absence of Written Procedures |
| 1777 | 21 CFR 211.150(b) | Distribution Recall System |
| 1891 | 21 CFR 211.165(f) | Failing drug products not rejected |
| 1912 | 21 CFR 211.166(a) | Written program not followed |
| 2027 | 21 CFR 211.192 | Investigations of discrepancies, failures |
| 4404 | 21 CFR 211.194(a)(1) | Sample identification and other information |
| 8906 | 21 CFR 314.81(b)(1)(i) | Mix-up |
| 8907 | 21 CFR 314.81(b)(1)(ii) | Contamination, chemical or physical change, deterioration |