Zydus Pharmaceuticals (USA) Inc, Pennington, NJ – FDA Inspections

Inspection records and compliance data for Zydus Pharmaceuticals (USA) Inc in Pennington, New Jersey. 5 FDA inspections on record, last inspected February 27, 2020.

Company Profile

This profile covers Zydus Pharmaceuticals (USA) Inc based in Pennington, New Jersey, United States.

FDA Inspection History

FDA inspections: 5
OAI: 0
VAI: 1
NAI: 4
Form 483s: 0
Warning letters: 0

First inspected August 11, 2009. Last inspected February 27, 2020.

Most cited issue areas

Failure to review ADE information1 inspection

FDA inspections (5)

Date	Result	FDA center(s)	Insp. #
February 27, 2020	NAI	Human Drugs · Bioresearch Monitoring	1122499
May 15, 2014	NAI	Human Drugs · Bioresearch Monitoring	878016
February 22, 2011	VAI	Human Drugs · Bioresearch Monitoring	710971
June 14, 2010	NAI	Human Drugs · Drug Quality Assurance	666881
August 11, 2009	NAI	Human Drugs · Drug Quality Assurance	605085

FDA documents

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

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