BAXTER HEALTHCARE CORPORATION — FDA Facility Profile
BAXTER HEALTHCARE CORPORATION is an FDA-registered facility (FEI 2025695) located in IRVINE, CA, US. RegDataLab tracks 3 FDA inspections and 1 compliance action at this facility.
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What FDA found at this site
- Latest inspection
- Mar 3, 2017: No Action Indicated (NAI)
- Inspections on record
- 3 (1 OAI, 2 NAI)
- Last OAI inspection
- Jun 5, 2013
- Warning letters
- 1 listed by FDA for this FEI, latest Dec 19, 2013
Inspections and what FDA cited
| Date | Result | What FDA cited |
|---|---|---|
| Mar 3, 2017 | No Action Indicated (NAI) | Documentation (21 CFR 820.75(a)) Calibration procedures - content (21 CFR 820.72(b)) Nonconforming product, Lack of or inadequate procedures (21 CFR 820.90(a)) Documentation (21 CFR 820.100(b)) |
| Dec 10, 2015 | No Action Indicated (NAI) | No citations listed |
| Jun 5, 2013 | Official Action Indicated (OAI) | No citations listed |
Facility details
- Company
- Baxter Healthcare Corporation
- Location
- IRVINE, CA (US)
- Source
- device