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•United States

Baxter Healthcare Corporation, Mountain View, CA – FDA Inspections

Inspection records and compliance data for Baxter Healthcare Corporation in Mountain View, California. 4 FDA inspections on record, 1 Form 483, last inspected November 29, 2016.

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Company Profile

This profile covers Baxter Healthcare Corporation based in Mountain View, California, United States.

FDA Inspection History

FDA inspections
4
OAI
0
VAI
3
NAI
1
Form 483s
1
Warning letters
0

First inspected January 5, 2011. Last inspected November 29, 2016.

Most cited issue areas

  • Approval, inadequate purchasing data1 inspection
  • Design changes - Lack of or Inadequate Procedures1 inspection
  • Design Validation - Risk analysis not performed/inadequate1 inspection

FDA inspections (4)

DateResultFDA center(s)Insp. #
November 29, 2016VAIMedical Devices & Rad Health · Compliance: Devices1000057
July 12, 2013NAIMedical Devices & Rad Health · Compliance: Devices839920
May 10, 2011VAIMedical Devices & Rad Health · Compliance: Devices724794
January 5, 2011VAIMedical Devices & Rad Health · Bioresearch Monitoring712413
FDA documents

No Form 483s, Warning Letters or EIRs on record.

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Monterey Medical Solutions, Inc.
Company Information

Name

Baxter Healthcare Corporation

FEI Number

3006472186

Address

835 Maude Ave, Mountain View, California 94043, United States

Country

United States

ID: 7918c709-8912-4fdc-afa8-5cc412885f1a

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