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•United States

Flexbar Machine Corp, Islandia, NY – FDA Inspections

Inspection records and compliance data for Flexbar Machine Corp in Islandia, New York. 5 FDA inspections on record, 2 Form 483s, last inspected April 04, 2025.

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Company Profile

This profile covers Flexbar Machine Corp based in Islandia, New York, United States.

FDA Inspection History

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

First inspected October 30, 2009. Last inspected April 4, 2025.

Most cited issue areas

  • Identification procedures, Lack of or inadequate procedures1 inspection
  • Lack of Written MDR Procedures1 inspection
  • Reports and information documentation1 inspection

FDA inspections (5)

DateResultFDA center(s)Insp. #
April 4, 2025NAIMedical Devices & Rad Health · Compliance: Medical Devices1266364
April 4, 2018VAIMedical Devices & Rad Health · Compliance: Devices1047534
July 22, 2014NAIMedical Devices & Rad Health · Compliance: Devices888627
May 1, 2012NAIMedical Devices & Rad Health · Compliance: Devices779265
October 30, 2009VAIMedical Devices & Rad Health · Postmarket Assurance: Devices625749
FDA documents

Form 483s (1)

  • Form 483s · April 4, 2025
People (1)
Kwong P. Lee
Person
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Company Information

Name

Flexbar Machine Corp

FEI Number

2424366

Address

250 Gibbs Rd, Islandia, New York 11749, United States

Country

United States

ID: 9998315c-237d-4866-98c5-8958437449d3

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