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•United States

Amerigen Pharmaceuticals Inc., Lyndhurst, NJ – FDA Inspections

Inspection records and compliance data for Amerigen Pharmaceuticals Inc. in Lyndhurst, New Jersey. 2 FDA inspections on record, 1 Form 483, last inspected January 18, 2019.

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Company Profile

This profile covers Amerigen Pharmaceuticals Inc. based in Lyndhurst, New Jersey, United States.

FDA Inspection History

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

First inspected July 27, 2017. Last inspected January 18, 2019.

Most cited issue areas

  • Failure to develop written procedures1 inspection

FDA inspections (2)

DateResultFDA center(s)Insp. #
January 18, 2019NAIHuman Drugs · Bioresearch Monitoring1077150
July 27, 2017VAIHuman Drugs · Postmarket Surv. and Epidemiology1019314
FDA documents

Form 483s (1)

  • Form 483s · July 27, 2017

EIRs (2)

  • EIRs · January 18, 2019
  • EIRs · July 27, 2017
People (3)
Anastasia Offordile
Person
Joanne Leonard
Person
Michael Serrano
Person
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Company Information

Name

Amerigen Pharmaceuticals Inc.

FEI Number

3008849302

Address

9 Polito Ave Ste 900, Lyndhurst, New Jersey 07071, United States

Country

United States

ID: 249d618c-b415-40b6-b86d-53c20e6e7db8

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