Baxter Healthcare Corporation — FDA Facility Profile
Baxter Healthcare Corporation is an FDA-inspected facility (FEI 3006472186) located in Mountain View, CA, US. RegDataLab tracks 4 FDA inspections at this facility.
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What FDA found at this site
- Latest inspection
- Nov 29, 2016: Voluntary Action Indicated (VAI)
- Inspections on record
- 4 (3 VAI, 1 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 Oct 17, 2014
- Import refusals
- 1
Inspections and what FDA cited
| Date | Result | What FDA cited |
|---|---|---|
| Nov 29, 2016 | Voluntary Action Indicated (VAI) | No citations listed |
| Jul 12, 2013 | No Action Indicated (NAI) | No citations listed |
| May 10, 2011 | Voluntary Action Indicated (VAI) | No citations listed |
| Jan 5, 2011 | Voluntary Action Indicated (VAI) | Sponsor device shipment records inadequate (21 CFR 812.140(b)(2)) |
Recalls
| Date | Class | Recall | Product and reason |
|---|---|---|---|
| Oct 17, 2014 | Class II | Z-2687-2017 | Tenaxis Medical ArterX(TM) Surgical Sealant, (a) 4mL, REF 9002, and (b) 5mL REF 9006… Product was improperly labeled leading to improper storage. |
Facility details
- Company
- Baxter Healthcare Corporation
- Location
- Mountain View, CA (US)
- Source
- inspections