FDA Inspection 1002594 — Roche Diabetes Care GmbH
The FDA completed an inspection of Roche Diabetes Care GmbH on February 2, 2017 in Mannheim. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 1 citation was issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- February 2, 2017
- Fiscal Year
- 2017
- Product Type
- Devices
- Project Area
- Postmarket Assurance: Devices
- Location
- Mannheim (Germany)
Citations
| ID | CFR | Description |
|---|---|---|
| 3173 | 21 CFR 820.198(d) | Evaluation, timeliness, identification |