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FDA Inspection
•Ingenus Pharmaceuticals GmbH•October 31, 2017

Ingenus Pharmaceuticals GmbH – FDA Inspection, Oct 31, 2017

Record Details

This FDA Inspection record concerns Ingenus Pharmaceuticals GmbH, with an inspection on October 31, 2017, issued by the Center for Drug Evaluation and Research, covering drugs.

Company
Ingenus Pharmaceuticals GmbH
Inspection Date
October 31, 2017
Product Type
Drugs
Office
Center for Drug Evaluation and Research
People
  • Samantha J. Bradley (FDA Associated Person)
  • Wayne E. Seifert (Senior Regulatory Specialist)
View Company Profile

ID · 8c8bead2-8a44-454f-86a5-e331f7849dd1

Inspection Facts

Voluntary Action Indicated (VAI)

Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.

Inspection number
1034770
FDA center
Human Drugs
Project area
Drug Quality Assurance
Outcome
Form 483 issued

Other FDA inspections of Ingenus Pharmaceuticals GmbH

4
DateClassificationOfficeProject area
October 3, 2024Not classifiedOffice of Inspections and Investigations
December 3, 2019NAICenter for Drug Evaluation and ResearchDrug Quality Assurance
December 11, 2018VAIOffice of Inspections and InvestigationsGeneric Drug Evaluation
November 4, 2014VAICenter for Drug Evaluation and ResearchDrug Quality Assurance
Other documents for Ingenus Pharmaceuticals GmbH
  • FDA Inspection 1263921 - 2024-10-03
  • FDA Inspection 1115845 - 2019-12-03
  • FDA Inspection 1074093 - 2018-12-11
  • FDA Inspection 905257 - 2014-11-04

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