FDA Inspection 948198 — Abbott Diabetes Care, Inc.
The FDA completed an inspection of Abbott Diabetes Care, Inc. on Oct 22, 2015 in Alameda, CA. 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: Devices.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Oct 22, 2015
- Fiscal Year
- 2016
- Product Type
- Devices
- Project Area
- Postmarket Assurance: Devices
- Location
- Alameda, CA (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 14713 | 21 CFR 820.198(a) | Lack of or inadequate complaint procedures |
| 3671 | 21 CFR 820.25(a) | Personnel |
| 732 | 21 CFR 803.50(a)(2) | Individual Report of Malfunction |