FDA Inspection 996367 — Roche Pharma AG
The FDA completed an inspection of Roche Pharma AG on Nov 25, 2016 in Grenzach-Wyhlen. 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
- Nov 25, 2016
- Fiscal Year
- 2017
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Grenzach-Wyhlen (Germany)
Citations
| ID | CFR | Description |
|---|---|---|
| 1809 | 21 CFR 211.160(a) | Following/documenting laboratory controls |
| 3603 | 21 CFR 211.160(b) | Scientifically sound laboratory controls |
| 4382 | 21 CFR 211.198(b)(2) | Written record of complaint to include findings, follow-up |