FDA Inspection 874281 — Roche Diagnostics GmbH
The FDA completed an inspection of Roche Diagnostics GmbH on Apr 4, 2014 in Mannheim. 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
- Apr 4, 2014
- Fiscal Year
- 2014
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Mannheim (Germany)
Citations
| ID | CFR | Description |
|---|---|---|
| 1451 | 21 CFR 211.113(b) | Procedures for sterile drug products |
| 4412 | 21 CFR 211.194(a)(7) | Signatures and dates--person who performs test |