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FDA Inspection
•Octapharma Pharmazeutika Produktionsgesellschaft m.b.H.•January 17, 2017

Octapharma Pharmazeutika Produktionsgesellschaft m.b.H. – FDA Inspection, Jan 17, 2017

Record Details

This FDA Inspection record concerns Octapharma Pharmazeutika Produktionsgesellschaft m.b.H., with an inspection on January 17, 2017, issued by the Center for Biologics Evaluation and Research, covering biologics.

Company
Octapharma Pharmazeutika Produktionsgesellschaft m.b.H.
Inspection Date
January 17, 2017
Product Type
Biologics
Office
Center for Biologics Evaluation and Research
People
  • Burnell M. Henry (FDA Associated Person)
  • Mihaly S. Ligmond (FDA Associated Person)
View Company Profile

ID · dbc69e2f-7dc6-4686-823b-67e414e440a4

Inspection Facts

Voluntary Action Indicated (VAI)

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

Inspection number
1002598
FDA center
Biologics
Project area
Blood and Blood Products
Outcome
Form 483 issued

Other FDA inspections of Octapharma Pharmazeutika Produktionsgesellschaft m.b.H.

4
DateClassificationOfficeProject area
December 16, 2022VAICenter for Biologics Evaluation and ResearchBlood and Blood Products
April 16, 2019VAICenter for Biologics Evaluation and ResearchBlood and Blood Products
March 5, 2015VAICenter for Biologics Evaluation and ResearchBlood and Blood Products
December 18, 2012VAICenter for Biologics Evaluation and ResearchBlood and Blood Products
Other documents for Octapharma Pharmazeutika Produktionsgesellschaft m.b.H.
  • FDA Inspection 1194258 - 2022-12-16
  • FDA Inspection 1090370 - 2019-04-16
  • FDA Inspection 918160 - 2015-03-05
  • FDA Inspection 816229 - 2012-12-18

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