FDA Inspection 982441 — Temmentech AG
The FDA completed an inspection of Temmentech AG on June 17, 2016 in Sumiswald. The inspection was classified OAI (Official Action Indicated — objectionable conditions were found and regulatory action is recommended). 12 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Official Action Indicated (OAI) (OAI)
- End Date
- June 17, 2016
- Fiscal Year
- 2016
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Sumiswald (Switzerland)
Citations
| ID | CFR | Description |
|---|---|---|
| 1177 | 21 CFR 211.63 | Equipment Design, Size and Location |
| 1213 | 21 CFR 211.67(a) | Cleaning / Sanitizing / Maintenance |
| 1215 | 21 CFR 211.67(b) | Written procedures not established/followed |
| 1263 | 21 CFR 211.68(b) | Computer control of master formula records |
| 1767 | 21 CFR 211.137(a) | Expiration date lacking |
| 1790 | 21 CFR 211.80(b) | Handling and Storage to Prevent Contamination |
| 1890 | 21 CFR 211.165(e) | Test methods |
| 1891 | 21 CFR 211.165(f) | Failing drug products not rejected |
| 2011 | 21 CFR 211.188(a) | Accurate reproduction |
| 3585 | 21 CFR 211.110(a) | Control procedures to monitor and validate performance |
| 4391 | 21 CFR 211.180(e)(2) | Items to cover on annual reviews |
| 4401 | 21 CFR 211.186(b)(9) | Complete instructions, procedures, specifications et. al. |