1114778
ProFresh International Corp. — FEI 3003273521
Inspection Details
- Classification
- Official Action Indicated (OAI) (OAI)
- End Date
- January 10, 2020
- Fiscal Year
- 2020
- 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 |
| 1777 | 21 CFR 211.150(b) | Distribution Recall System |
| 1890 | 21 CFR 211.165(e) | Test methods |
| 1914 | 21 CFR 211.166(a) | Lack of written stability program |
| 4389 | 21 CFR 211.198(a) | Procedures to be written and followed |