Guy & O'Neill, Inc, Reidsville, NC – FDA Inspections

Inspection records and compliance data for Guy & O'Neill, Inc in Reidsville, North Carolina. 5 FDA inspections on record, last inspected July 25, 2017.

Company Profile

This profile covers Guy & O'Neill, Inc based in Reidsville, North Carolina, United States.

FDA Inspection History

FDA inspections: 5
OAI: 0
VAI: 2
NAI: 3
Form 483s: 0
Warning letters: 0

First inspected January 26, 2011. Last inspected July 25, 2017.

Most cited issue areas

Calibration, Inspection, etc. Procedures Lack of or Inadequ1 inspection
Contamination control, Lack of or inadequate procedures1 inspection
Design changes - Lack of or Inadequate Procedures1 inspection

FDA inspections (5)

Date	Result	FDA center(s)	Insp. #
July 25, 2017	NAI	Medical Devices & Rad Health · Compliance: Devices	1022791
February 12, 2016	VAI	Human Drugs · Drug Quality Assurance	964874
March 21, 2014	NAI	Medical Devices & Rad Health · Compliance: Devices	871230
May 30, 2012	NAI	Human Drugs · Drug Quality Assurance	786218
January 26, 2011	VAI	Medical Devices & Rad Health · Compliance: Devices	703350

FDA documents

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

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