FDA Inspection 1259651 — Baxter Corporation
The FDA completed an inspection of Baxter Corporation on January 31, 2025 in Alliston. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 4 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- January 31, 2025
- Fiscal Year
- 2025
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Alliston (Canada)
Citations
| ID | CFR | Description |
|---|---|---|
| 1790 | 21 CFR 211.80(b) | Handling and Storage to Prevent Contamination |
| 3567 | 21 CFR 211.84(d)(2) | Component identification test |
| 3585 | 21 CFR 211.110(a) | Control procedures to monitor and validate performance |
| 4402 | 21 CFR 211.192 | Written record of investigation incomplete |