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•United States

Braemar Manufacturing, LLC, Eagan, MN – FDA Inspections

Inspection records and compliance data for Braemar Manufacturing, LLC in Eagan, Minnesota. 3 FDA inspections on record, 1 Form 483, last inspected November 02, 2017.

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Company Profile

This profile covers Braemar Manufacturing, LLC based in Eagan, Minnesota, United States.

FDA Inspection History

FDA inspections
3
OAI
0
VAI
1
NAI
2
Form 483s
1
Warning letters
0

First inspected March 24, 2010. Last inspected November 2, 2017.

Most cited issue areas

  • Design Validation - Risk analysis not performed/inadequate1 inspection
  • Lack of or inadequate procedures1 inspection

FDA inspections (3)

DateResultFDA center(s)Insp. #
November 2, 2017VAIMedical Devices & Rad Health · Compliance: Devices1030857
February 20, 2013NAIMedical Devices & Rad Health · Compliance: Devices819115
March 24, 2010NAIMedical Devices & Rad Health · Compliance: Devices653191
FDA documents

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

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Janzen, Mark A. Ph.D., Clinical Investigator
Annova Enterprises, Inc.
Earlitec Diagnostics
Company Information

Name

Braemar Manufacturing, LLC

FEI Number

1000520785

Address

1285 Corporate Center Dr Ste 150, Eagan, Minnesota 55121, United States

Country

United States

ID: ee5c6a7c-edac-4a51-b890-5da06890fdf1

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