Baxter Corporation — FDA Facility Profile
Baxter Corporation is an FDA-registered facility (FEI 3002891260) located in Alliston, CA. Registered operations: ANALYSIS; LABEL; MANUFACTURE; PACK; STERILIZE. RegDataLab tracks 4 FDA inspections at this facility.
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What FDA found at this site
- Latest inspection
- Jan 31, 2025: Voluntary Action Indicated (VAI)
- Inspections on record
- 4 (2 VAI, 2 NAI)
- Last OAI inspection
- None on record
- Warning letters
- None matched to this FEI. Many letters do not state an FEI: search warning letters by company name
- Import refusals
- 10 or more
Inspections and what FDA cited
| Date | Result | What FDA cited |
|---|---|---|
| Jan 31, 2025 | Voluntary Action Indicated (VAI) | Handling and Storage to Prevent Contamination (21 CFR 211.80(b)) Component identification test (21 CFR 211.84(d)(2)) Control procedures to monitor and validate performance (21 CFR 211.110(a)) Written record of investigation incomplete (21 CFR 211.192) |
| Sep 17, 2019 | Voluntary Action Indicated (VAI) | Procedures for sterile drug products (21 CFR 211.113(b)) Storage under appropriate conditions (21 CFR 211.142(b)) |
| Jul 30, 2015 | No Action Indicated (NAI) | No citations listed |
| Apr 8, 2010 | No Action Indicated (NAI) | No citations listed |
Facility details
- Company
- Baxter Corporation
- Location
- Alliston (CA)
- Registration Expires
- Dec 31, 2027
- Operations
- ANALYSIS; LABEL; MANUFACTURE; PACK; STERILIZE
- Source
- decrs