FDA Inspection 635177 — Baxter Healthcare Renal Div
The FDA completed an inspection of Baxter Healthcare Renal Div on December 14, 2009 in Waukegan, IL. The inspection was classified OAI (Official Action Indicated — objectionable conditions were found and regulatory action is recommended). 8 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- Official Action Indicated (OAI) (OAI)
- End Date
- December 14, 2009
- Fiscal Year
- 2010
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- Waukegan, IL (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 3167 | 21 CFR 820.198(a) | Complete files maintained |
| 3369 | 21 CFR 820.198(a)(1) | Uniform and timely processing |
| 3381 | 21 CFR 820.198(e)(7) | Corrective action taken |
| 3675 | 21 CFR 820.30(f) | Design verification - unresolved discrepancies |
| 3690 | 21 CFR 820.100(a)(3) | Identification of actions needed |
| 486 | 21 CFR 820.50(a) | Evaluation of suppliers, contractors, etc., requirements |
| 731 | 21 CFR 803.50(a)(1) | Report of Death or Serious Injury |
| 732 | 21 CFR 803.50(a)(2) | Individual Report of Malfunction |