Ingenus Pharmaceuticals NJ, LLC., Fairfield, NJ – FDA Inspections

Inspection records and compliance data for Ingenus Pharmaceuticals NJ, LLC. in Fairfield, New Jersey. 13 FDA inspections on record, 3 Form 483s, last inspected July 17, 2026.

Company Profile

This profile covers Ingenus Pharmaceuticals NJ, LLC. based in Fairfield, New Jersey, United States.

FDA Inspection History

FDA inspections: 13
OAI: 0
VAI: 4
NAI: 7
Unclassified: 2
Form 483s: 3
Warning letters: 0

First inspected July 7, 2009. Last inspected July 17, 2026.

Most cited issue areas

Design and development inputs do not include all requirements1 inspection
Design and development procedures not documented1 inspection
Design and development verification not performed1 inspection

FDA inspections (13)

Date	Result	FDA center(s)	Insp. #
July 17, 2026	Not classified	Medical Devices & Rad Health · Compliance: Devices	1326668
January 9, 2026	Not classified	Human Drugs	1302128
February 18, 2022	NAI	Human Drugs · Drug Quality Assurance	1164226
January 24, 2019	NAI	Human Drugs · Drug Quality Assurance	1079060
December 14, 2017	VAI	Human Drugs · Generic Drug Evaluation	1035002
September 27, 2017	VAI	Human Drugs · Drug Quality Assurance	1026727
November 16, 2016	NAI	Human Drugs · Bioresearch Monitoring	994493
May 4, 2015	VAI	Human Drugs · Bioresearch Monitoring	924723
September 29, 2014	NAI	Human Drugs · Drug Quality Assurance	898420
October 22, 2013	NAI	Human Drugs · Drug Quality Assurance	852153
November 15, 2012	NAI	Human Drugs · Drug Quality Assurance	807379
March 24, 2010	NAI	Human Drugs · Drug Quality Assurance	653972
July 7, 2009	VAI	Human Drugs · Drug Quality Assurance	595669