FDA Inspection 680948 — Baxter Healthcare Corporation
The FDA completed an inspection of Baxter Healthcare Corporation on August 31, 2010 in Medina, NY. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 5 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- August 31, 2010
- Fiscal Year
- 2010
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- Medina, NY (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 3130 | 21 CFR 820.100(a) | Lack of or inadequate procedures |
| 3426 | 21 CFR 820.50(a)(1) | Documented evaluation |
| 3433 | 21 CFR 820.75(c) | Process changes - review, evaluation and revalidation |
| 4193 | 21 CFR 806.10(b) | Time to report - 10 days |
| 537 | 21 CFR 820.70(a) | Production processes |