Baxter Healthcare Corporation — FDA Facility Profile

FEI 1036337

Baxter Healthcare Corporation is an FDA-inspected facility (FEI 1036337) located in Largo, FL, US. RegDataLab tracks 4 FDA inspections at this facility.

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What FDA found at this site

Latest inspection
Aug 23, 2017: No Action Indicated (NAI)
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
2

A Form 483 lists an inspector's observations. OAI means FDA recommends regulatory and/or administrative action. A warning letter is FDA's formal enforcement notice. No record here does not establish that a site is safe. Check this site on FDA's Data Dashboard.

Inspections and what FDA cited

Newest first. Citations are the inspector observations FDA publishes for the inspection.

DateResultWhat FDA cited
Aug 23, 2017No Action Indicated (NAI)No citations listed
May 22, 2014Voluntary Action Indicated (VAI)Lack of or inadequate complaint procedures (21 CFR 820.198(a))
Lack of or inadequate procedures (21 CFR 820.100(a))
DHR content (21 CFR 820.184)
Nonconforming product, Lack of or inadequate procedures (21 CFR 820.90(a))
Feb 16, 2012No Action Indicated (NAI)No citations listed
Dec 16, 2009Voluntary Action Indicated (VAI)Procedure for analysis of data sources (21 CFR 820.100(a)(1))
General (21 CFR 820.198(a))

Facility details

Company
Baxter Healthcare Corporation
Location
Largo, FL (US)
Source
inspections

Sources: openFDA, FDA Data Dashboard, FDA.gov. Report a data issue: hello@regdatalab.com.