Nidek, Inc., Lewisville, TX – FDA Inspections

Inspection records and compliance data for Nidek, Inc. in Lewisville, TX. 7 FDA inspections on record (1 OAI), last inspected January 24, 2019.

Company Profile

This profile covers Nidek, Inc. based in Lewisville, TX, United States.

FDA Inspection History

FDA inspections: 7
OAI: 1
VAI: 2
NAI: 4
Form 483s: 0
Warning letters: 0

First inspected March 7, 2012. Last inspected January 24, 2019.

Most cited issue areas

Documentation3 inspections
DHR - not or inadequately maintained2 inspections
Lack of or inadequate complaint procedures2 inspections

FDA inspections (7)

Date	Result	FDA center(s)	Insp. #
January 24, 2019	NAI	Medical Devices & Rad Health · Postmarket Assurance: Devices	1078121
March 31, 2017	NAI	Medical Devices & Rad Health · Compliance: Devices	1009390
August 10, 2016	NAI	Medical Devices & Rad Health · Compliance: Devices	980717
June 10, 2015	NAI	Medical Devices & Rad Health · Compliance: Devices	930830
April 14, 2014	OAI	Medical Devices & Rad Health · Compliance: Devices	871244
July 30, 2013	VAI	Medical Devices & Rad Health · Postmarket Assurance: Devices	842321
March 7, 2012	VAI	Medical Devices & Rad Health · Compliance: Devices	770985

FDA documents

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

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