FDA Inspection 1051581 — F. Hoffmann - La Roche Ltd.
The FDA completed an inspection of F. Hoffmann - La Roche Ltd. on May 4, 2018 in Kaiseraugst. 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). 2 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- May 4, 2018
- Fiscal Year
- 2018
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Kaiseraugst (Switzerland)
Citations
| ID | CFR | Description |
|---|---|---|
| 2027 | 21 CFR 211.192 | Investigations of discrepancies, failures |
| 9089 | 21 CFR 600.14(c) | When to report |