FDA Inspection 1006633 — Baxter Healthcare Corporation
The FDA completed an inspection of Baxter Healthcare Corporation on Mar 3, 2017 in Irvine, CA. The inspection was classified NAI (No Action Indicated — no objectionable conditions or practices were found during the inspection). 4 citations were issued during this inspection. Product area: Devices.
Inspection details
- Classification
- No Action Indicated (NAI)
- End Date
- Mar 3, 2017
- Fiscal Year
- 2017
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- Irvine, CA (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 3118 | 21 CFR 820.75(a) | Documentation |
| 3236 | 21 CFR 820.72(b) | Calibration procedures - content |
| 3282 | 21 CFR 820.90(a) | Nonconforming product, Lack of or inadequate procedures |
| 3696 | 21 CFR 820.100(b) | Documentation |