FDA Inspection 1002397 — Sintetica S.A.
The FDA completed an inspection of Sintetica S.A. on December 6, 2016 in Mendrisio. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 3 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- December 6, 2016
- Fiscal Year
- 2017
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Mendrisio (Switzerland)
Citations
| ID | CFR | Description |
|---|---|---|
| 1451 | 21 CFR 211.113(b) | Procedures for sterile drug products |
| 1868 | 21 CFR 211.94(b) | Protection from external factors |
| 3603 | 21 CFR 211.160(b) | Scientifically sound laboratory controls |