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FDA Inspection
•Novartis Pharma S.A.S. - Centre de Biotechnologie•September 12, 2017

Novartis Pharma S.A.S. - Centre de Biotechnologie – FDA Inspection, Sep 12, 2017

Record Details

This FDA Inspection record concerns Novartis Pharma S.A.S. - Centre de Biotechnologie, with an inspection on September 12, 2017, issued by the Center for Drug Evaluation and Research, covering drugs.

Company
Novartis Pharma S.A.S. - Centre de Biotechnologie
Inspection Date
September 12, 2017
Product Type
Drugs
Office
Center for Drug Evaluation and Research
People
  • Carla J. Lundi (FDA Associated Person)
  • Xiaoping Guan (Company Rep)
View Company Profile

ID · 8615aa30-3785-4cab-af8d-bbcb1a2be973

Inspection Facts

Voluntary Action Indicated (VAI)

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

Inspection number
1026805
FDA center
Human Drugs
Project area
Drug Quality Assurance
Outcome
Form 483 issued

Other FDA inspections of Novartis Pharma S.A.S. - Centre de Biotechnologie

3
DateClassificationOfficeProject area
November 19, 2020VAICenter for Drug Evaluation and ResearchDrug Quality Assurance
March 18, 2014VAICenter for Drug Evaluation and ResearchDrug Quality Assurance
January 31, 2012VAICenter for Drug Evaluation and ResearchDrug Quality Assurance
Other documents for Novartis Pharma S.A.S. - Centre de Biotechnologie
  • FDA Inspection 1173120 - 2020-11-19
  • FDA Inspection 878418 - 2014-03-18
  • FDA Inspection 787415 - 2012-01-31

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