FDA Inspection 657184 — Baxter Healthcare Corporation
The FDA completed an inspection of Baxter Healthcare Corporation on Mar 29, 2010 in Deerfield, IL. 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). 8 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Mar 29, 2010
- Fiscal Year
- 2010
- Product Type
- Devices
- Project Area
- Postmarket Assurance: Devices
- Location
- Deerfield, IL (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 2327 | 21 CFR 820.22 | Quality audits - Lack of or inadequate procedures |
| 3299 | 21 CFR 820.100(a)(1) | Procedure for analysis of data sources |
| 3304 | 21 CFR 820.100(a)(5) | Changes to correct/prevent quality problems |
| 3427 | 21 CFR 820.50(a)(2) | Supplier oversight |
| 3667 | 21 CFR 820.20(c) | Management review accomplishment |
| 3687 | 21 CFR 820.100(a)(1) | Analysis of data sources |
| 3692 | 21 CFR 820.100(a)(4) | CAPA verification/validation of corrective/preventive action |
| 4059 | 21 CFR 820.22 | Quality Audits - defined intervals |