1100901
Bioforce AG — FEI 3003325095
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- August 23, 2019
- Fiscal Year
- 2019
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Roggwil Tg (Switzerland)
Citations
| ID | CFR | Description |
|---|
| 1177 | 21 CFR 211.63 | Equipment Design, Size and Location |
| 1215 | 21 CFR 211.67(b) | Written procedures not established/followed |
| 1626 | 21 CFR 211.130 | Procedures are written, and followed |
| 1914 | 21 CFR 211.166(a) | Lack of written stability program |
| 1942 | 21 CFR 211.180(e) | Records reviewed annually |
| 3583 | 21 CFR 211.110(a) | Written in-process control procedures |
| 4303 | 21 CFR 211.67(b) | Written procedures fail to include |