FDA Inspection 1117098 — Jetpharma SA
The FDA completed an inspection of Jetpharma SA on February 7, 2020 in Balerna. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 2 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- February 7, 2020
- Fiscal Year
- 2020
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Balerna (Switzerland)
Citations
| ID | CFR | Description |
|---|---|---|
| 2401 | 21 CFR 211.194(a)(4) | Complete Test Data |
| 4342 | 21 CFR 211.142(b) | Storage under appropriate conditions |