FDA Inspection 1116611 — Siegfried Pharma AG
The FDA completed an inspection of Siegfried Pharma AG on December 13, 2019 in Zofingen. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 5 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- December 13, 2019
- Fiscal Year
- 2020
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Zofingen (Switzerland)
Citations
| ID | CFR | Description |
|---|---|---|
| 1177 | 21 CFR 211.63 | Equipment Design, Size and Location |
| 1213 | 21 CFR 211.67(a) | Cleaning / Sanitizing / Maintenance |
| 1883 | 21 CFR 211.165(a) | Testing and release for distribution |
| 3611 | 21 CFR 211.160(b)(3) | Acceptance of drug products |
| 4391 | 21 CFR 211.180(e)(2) | Items to cover on annual reviews |