FDA Inspection 645900 — Abbott Diabetes Care, Inc.
The FDA completed an inspection of Abbott Diabetes Care, Inc. on March 5, 2010 in Alameda, CA. The inspection was classified OAI (Official Action Indicated — objectionable conditions were found and regulatory action is recommended). 9 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- Official Action Indicated (OAI) (OAI)
- End Date
- March 5, 2010
- Fiscal Year
- 2010
- Product Type
- Devices
- Project Area
- Postmarket Assurance: Devices
- Location
- Alameda, CA (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 2279 | 21 CFR 820.20(b)(2) | Resources |
| 2327 | 21 CFR 820.22 | Quality audits - Lack of or inadequate procedures |
| 3101 | 21 CFR 820.30(g) | Design validation- Lack of or inadequate procedures |
| 3121 | 21 CFR 820.80(b) | Lack of or inadequate receiving acceptance procedures |
| 3128 | 21 CFR 820.90(a) | Nonconforming product control |
| 3130 | 21 CFR 820.100(a) | Lack of or inadequate procedures |
| 3172 | 21 CFR 820.198(c) | Investigation of device failures |
| 3370 | 21 CFR 820.198(a)(2) | Oral complaints |
| 546 | 21 CFR 820.75(a) | Lack of or inadequate process validation |