Unitron Hearing Inc, Minneapolis, MN – FDA Inspections

Inspection records and compliance data for Unitron Hearing Inc in Minneapolis, Minnesota. 3 FDA inspections on record, last inspected April 04, 2017.

Company Profile

This profile covers Unitron Hearing Inc based in Minneapolis, Minnesota, United States.

FDA Inspection History

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

First inspected December 3, 2009. Last inspected April 4, 2017.

Most cited issue areas

Documentation1 inspection
Lack of or inadequate complaint procedures1 inspection
Lack of or inadequate procedures1 inspection

FDA inspections (3)

Date	Result	FDA center(s)	Insp. #
April 4, 2017	NAI	Medical Devices & Rad Health · Compliance: Devices	1012389
January 12, 2016	VAI	Medical Devices & Rad Health · Compliance: Devices	977966
December 3, 2009	NAI	Medical Devices & Rad Health · Compliance: Devices	632332

FDA documents

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

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