FDA Inspection 1293034 — Baxter Healthcare Corporation
The FDA completed an inspection of Baxter Healthcare Corporation on Nov 25, 2025 in Round Lake, 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). 5 citations were issued during this inspection. Product area: Biologics.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Nov 25, 2025
- Fiscal Year
- 2026
- Product Type
- Biologics
- Project Area
- Blood and Blood Products
- Location
- Round Lake, IL (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1105 | 21 CFR 211.22(d) | Procedures not in writing, fully followed |
| 1111 | 21 CFR 211.25(a) | Training , Education , Experience overall |
| 1263 | 21 CFR 211.68(b) | Computer control of master formula records |
| 3603 | 21 CFR 211.160(b) | Scientifically sound laboratory controls |
| 4404 | 21 CFR 211.194(a)(1) | Sample identification and other information |