FDA Inspection 798676 — Baxter Healthcare Corporation
The FDA completed an inspection of Baxter Healthcare Corporation on Aug 31, 2012 in Marion, NC. 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
- Aug 31, 2012
- Fiscal Year
- 2012
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- Marion, NC (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 3565 | 21 CFR 211.58 | Buildings not maintained in good state of repair |
| 3591 | 21 CFR 211.110(b) | In-process materials specifications |
| 8907 | 21 CFR 314.81(b)(1)(ii) | Contamination, chemical or physical change, deterioration |