FDA Inspection 577601 — Baxter Healthcare Corporation
The FDA completed an inspection of Baxter Healthcare Corporation on Apr 22, 2009 in Deerfield, IL. The inspection was classified OAI (Official Action Indicated — regulatory and/or administrative actions are recommended). 9 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- Official Action Indicated (OAI)
- End Date
- Apr 22, 2009
- Fiscal Year
- 2009
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- Deerfield, IL (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 2557 | 21 CFR 820.30(c) | Design input - documentation |
| 3103 | 21 CFR 820.30(i) | Design changes - Lack of or Inadequate Procedures |
| 3104 | 21 CFR 820.30(j) | Design history file |
| 3155 | 21 CFR 820.181(a) | DMR device specifications |
| 3206 | 21 CFR 820.50(b) | Approval, inadequate purchasing data |
| 3301 | 21 CFR 820.100(a)(2) | Investigation procedures |
| 3425 | 21 CFR 820.50(a)(1) | Evaluation and Selection, Suppliers, Contractors, etc. |
| 3690 | 21 CFR 820.100(a)(3) | Identification of actions needed |
| 4058 | 21 CFR 820.20 | Management responsibility |