FDA Inspection 1014881 — Swiss Caps AG
The FDA completed an inspection of Swiss Caps AG on June 16, 2017 in Kirchberg SG. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 4 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- June 16, 2017
- Fiscal Year
- 2017
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Kirchberg SG (Switzerland)
Citations
| ID | CFR | Description |
|---|---|---|
| 1890 | 21 CFR 211.165(e) | Test methods |
| 3603 | 21 CFR 211.160(b) | Scientifically sound laboratory controls |
| 4305 | 21 CFR 211.68(b) | Backup data not assured as exact and complete |
| 4576 | 21 CFR 211.192 | No written record of investigation |