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•United States

The Flexite Company, Mineola, NY – FDA Inspections

Inspection records and compliance data for The Flexite Company in Mineola, New York. 6 FDA inspections on record, 1 Form 483, last inspected June 01, 2022.

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Company Profile

This profile covers The Flexite Company based in Mineola, New York, United States.

FDA Inspection History

FDA inspections
6
OAI
0
VAI
4
NAI
2
Form 483s
1
Warning letters
0

First inspected October 8, 2008. Last inspected June 1, 2022.

Most cited issue areas

  • Complaints1 inspection
  • Document change records, maintained.1 inspection
  • Document review, approval documentation1 inspection

FDA inspections (6)

DateResultFDA center(s)Insp. #
June 1, 2022NAIMedical Devices & Rad Health · Postmarket Assurance: Devices1172026
October 5, 2018VAIMedical Devices & Rad Health · Compliance: Devices1068392
November 19, 2015VAIMedical Devices & Rad Health · Compliance: Devices951140
January 9, 2013VAIMedical Devices & Rad Health · Compliance: Devices813877
January 19, 2011VAIMedical Devices & Rad Health · Compliance: Devices706613
October 8, 2008NAIMedical Devices & Rad Health · Compliance: Devices541724
FDA documents

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

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David J. Fiorella, MD, PhD
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Underwriters Laboratories, Inc.
Sure Inc.
Company Information

Name

The Flexite Company

FEI Number

2432071

Address

40 Roselle St, Mineola, New York 11501, United States

Country

United States

ID: c095b520-5859-4ec0-98fd-901e5f733bb5

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