Immucor GTI Diagnostics, Inc, Waukesha, WI – FDA Inspections

Inspection records and compliance data for Immucor GTI Diagnostics, Inc in Waukesha, Wisconsin. 2 FDA inspections on record, last inspected February 01, 2016.

Company Profile

This profile covers Immucor GTI Diagnostics, Inc based in Waukesha, Wisconsin, United States.

FDA Inspection History

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

First inspected January 13, 2010. Last inspected February 1, 2016.

Most cited issue areas

Acceptance criteria and essential outputs1 inspection
Design review - Lack of or inadequate procedures1 inspection
Design validation- Lack of or inadequate procedures1 inspection

FDA inspections (2)

Date	Result	FDA center(s)	Insp. #
February 1, 2016	VAI	Medical Devices & Rad Health · Compliance: Devices	977541
January 13, 2010	VAI	Medical Devices & Rad Health · Compliance: Devices	639478

FDA documents

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

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