FDA Inspection 984591 — Roche Diagnostics Operations, Inc.
The FDA completed an inspection of Roche Diagnostics Operations, Inc. on August 15, 2016 in Indianapolis, IN. 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
- August 15, 2016
- Fiscal Year
- 2016
- Product Type
- Devices
- Project Area
- Postmarket Assurance: Devices
- Location
- Indianapolis, IN (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 4191 | 21 CFR 806.10(a)(1) | Report of risk to health |