FDA Inspection 1177103 — F. Hoffmann - La Roche Ltd.
The FDA completed an inspection of F. Hoffmann - La Roche Ltd. on Aug 5, 2022 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). 3 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Aug 5, 2022
- Fiscal Year
- 2022
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Kaiseraugst (Switzerland)
Citations
| ID | CFR | Description |
|---|---|---|
| 1434 | 21 CFR 211.42(c)(10)(iv) | Environmental Monitoring System |
| 3547 | 21 CFR 211.46(b) | Equipment for Environmental Control |
| 4402 | 21 CFR 211.192 | Written record of investigation incomplete |