FDA Inspection 651127 — Ascensia Diabetes Care U.S. Inc.
The FDA completed an inspection of Ascensia Diabetes Care U.S. Inc. on Mar 12, 2010 in Mishawaka, IN. 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). 1 citation was issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Mar 12, 2010
- Fiscal Year
- 2010
- Product Type
- Devices
- Project Area
- Postmarket Assurance: Devices
- Location
- Mishawaka, IN (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 783 | 21 CFR 803.52(f)(6) | Evaluation Codes |