FDA Inspection 1193140 — Hanseler AG
The FDA completed an inspection of Hanseler AG on Oct 21, 2022 in Herisau. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions or practices were found, but the agency is not prepared to take or recommend any administrative or regulatory action). 4 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Oct 21, 2022
- Fiscal Year
- 2023
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Herisau (Switzerland)
Citations
| ID | CFR | Description |
|---|---|---|
| 1843 | 21 CFR 211.84(d)(2) | Component written specification |
| 2027 | 21 CFR 211.192 | Investigations of discrepancies, failures |
| 3571 | 21 CFR 211.100(a) | Changes to Procedures Not Reviewed, Approved |
| 3585 | 21 CFR 211.110(a) | Control procedures to monitor and validate performance |