BAXTER HEALTHCARE CORPORATION — FDA Facility Profile
BAXTER HEALTHCARE CORPORATION is an FDA-registered facility (FEI 2937398) located in HAYWARD, CA, US. RegDataLab tracks 4 FDA inspections at this facility.
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What FDA found at this site
- Latest inspection
- May 5, 2015: No Action Indicated (NAI)
- Inspections on record
- 4 (1 VAI, 3 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
- Recalls as the recalling firm
- 1, latest May 12, 2016
- Import refusals
- 9
Inspections and what FDA cited
| Date | Result | What FDA cited |
|---|---|---|
| May 5, 2015 | No Action Indicated (NAI) | No citations listed |
| Aug 24, 2012 | Voluntary Action Indicated (VAI) | Contamination control, Lack of or inadequate procedures (21 CFR 820.70(e)) Lack of or inadequate procedures (21 CFR 820.100(a)) Environmental control Lack of or inadequate procedures (21 CFR 820.70(c)) |
| Apr 23, 2010 | No Action Indicated (NAI) | No citations listed |
| Apr 7, 2009 | No Action Indicated (NAI) | No citations listed |
Recalls
| Date | Class | Recall | Product and reason |
|---|---|---|---|
| May 12, 2016 | Class II | Z-1838-2016 | COSEAL Surgical Sealant Kit, 2 mL, Product Code: 934070; For use in vascular… and 2 more products Potential for incomplete dissolution of the polyethylene glycol (PEG) component during the reconstitution of the product, which may affect… |
Facility details
- Company
- Baxter Healthcare Corp
- Location
- HAYWARD, CA (US)
- Source
- device