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FDA Inspection
•Janssen Research & Development•March 26, 2015

Janssen Research & Development – FDA Inspection, Mar 26, 2015

Record Details

This FDA Inspection record concerns Janssen Research & Development, with an inspection on March 26, 2015, issued by the Center for Drug Evaluation and Research, covering drugs.

Company
Janssen Research & Development
Inspection Date
March 26, 2015
Product Type
Drugs
Office
Center for Drug Evaluation and Research
View Company Profile

ID · d4bb6585-bc71-4322-9420-94f3ce505f0b

Inspection Facts

Voluntary Action Indicated (VAI)

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

Inspection number
922964
FDA center
Human Drugs
Project area
Bioresearch Monitoring

FDA Citations

2
  1. 21 CFR 312.50General responsibilities of sponsors
  2. 21 CFR 312.50Ensuring compliance with plan and protocol

Full citation text and observation details available on the Dashboard.

Other FDA inspections of Janssen Research & Development

2
DateClassificationOfficeProject area
March 1, 2023NAICenter for Drug Evaluation and ResearchBioresearch Monitoring
July 30, 2015NAICenter for Drug Evaluation and ResearchBioresearch Monitoring
Other documents for Janssen Research & Development
  • FDA Inspection 1200327 - 2023-03-01
  • FDA Inspection 936659 - 2015-07-30

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