Baxter Healthcare Corporation — FDA Facility Profile
Baxter Healthcare Corporation is an FDA-inspected facility (FEI 2650090) located in Guayama, PR, US. RegDataLab tracks 9 FDA inspections and 1 compliance action at this facility.
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What FDA found at this site
- Latest inspection
- Mar 26, 2025: Voluntary Action Indicated (VAI)
- Inspections on record
- 9 (1 OAI, 3 VAI, 5 NAI)
- Last OAI inspection
- Sep 30, 2010
- Warning letters
- 1 listed by FDA for this FEI, latest Jan 20, 2011
- Import refusals
- 2
Inspections and what FDA cited
| Date | Result | What FDA cited |
|---|---|---|
| Mar 26, 2025 | Voluntary Action Indicated (VAI) | Procedures not in writing, fully followed (21 CFR 211.22(d)) |
| Sep 16, 2020 | No Action Indicated (NAI) | No citations listed |
| Oct 24, 2018 | Voluntary Action Indicated (VAI) | Buildings not maintained in good state of repair (21 CFR 211.58) In-process and laboratory control results (21 CFR 211.188(b)(5)) |
| Dec 13, 2016 | No Action Indicated (NAI) | No citations listed |
| Feb 6, 2015 | Voluntary Action Indicated (VAI) | Procedures not in writing, fully followed (21 CFR 211.22(d)) Written record of investigation incomplete (21 CFR 211.192) |
| Dec 4, 2013 | No Action Indicated (NAI) | No citations listed |
| May 18, 2012 | No Action Indicated (NAI) | No citations listed |
| Jun 30, 2011 | No Action Indicated (NAI) | No citations listed |
| Sep 30, 2010 | Official Action Indicated (OAI) | No citations listed |
Facility details
- Company
- Baxter Healthcare Corporation
- Location
- Guayama, PR (US)
- Source
- inspections