FDA Inspection 1153203 — Baxter Healthcare Corporation
The FDA completed an inspection of Baxter Healthcare Corporation on Sep 28, 2021 in Medina, NY. The inspection was classified NAI (No Action Indicated — no objectionable conditions or practices were found during the inspection). 1 citation was issued during this inspection. Product area: Devices.
Inspection details
- Classification
- No Action Indicated (NAI)
- End Date
- Sep 28, 2021
- Fiscal Year
- 2021
- Product Type
- Devices
- Project Area
- Postmarket Assurance: Devices
- Location
- Medina, NY (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 3677 | 21 CFR 820.30(g) | Design validation - software validation not performed |