FDA Inspection 850887 — Baxter Healthcare Corporation
The FDA completed an inspection of Baxter Healthcare Corporation on September 26, 2013 in Aibonito, PR. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 4 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- September 26, 2013
- Fiscal Year
- 2013
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- Aibonito, PR (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 3120 | 21 CFR 820.80(a) | Lack of or inadequate procedures - Acceptance activities |
| 3266 | 21 CFR 820.86 | Acceptance status |
| 4192 | 21 CFR 806.10(a)(2) | Report of violation of the Act (see 803.52(e)(9)) |
| 479 | 21 CFR 820.50 | Purchasing controls, Lack of or inadequate procedures |