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•United States

Spectronics Corp, Westbury, NY – FDA Inspections

Inspection records and compliance data for Spectronics Corp in Westbury, New York. 3 FDA inspections on record, 1 Form 483, last inspected January 30, 2020.

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Company Profile

This profile covers Spectronics Corp based in Westbury, New York, United States.

FDA Inspection History

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

First inspected December 7, 2009. Last inspected January 30, 2020.

Most cited issue areas

  • DHR content2 inspections
  • DHR - UDI not included1 inspection
  • DMR - not or inadequately maintained1 inspection

FDA inspections (3)

DateResultFDA center(s)Insp. #
January 30, 2020VAIMedical Devices & Rad Health · Postmarket Assurance: Devices1116900
April 5, 2017VAIMedical Devices & Rad Health · Compliance: Devices1006288
December 7, 2009NAIMedical Devices & Rad Health · Compliance: Devices632425
FDA documents

Form 483s (1)

  • Form 483s · January 30, 2020
People (1)
Kwong P. Lee
Person
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Company Information

Name

Spectronics Corp

FEI Number

2419818

Address

956 Brush Hollow Rd, Westbury, New York 11590, United States

Country

United States

ID: 65b60dab-f4c5-49cc-ad9a-f844f1e18baa

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