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FDA Inspection
•Diagnostic Grifols, S.A.•November 14, 2016

Diagnostic Grifols, S.A. – FDA Inspection, Nov 14, 2016

Record Details

This FDA Inspection record concerns Diagnostic Grifols, S.A., with an inspection on November 14, 2016, issued by the Center for Biologics Evaluation and Research, covering biologics.

Company
Diagnostic Grifols, S.A.
Inspection Date
November 14, 2016
Product Type
Biologics
Office
Center for Biologics Evaluation and Research
Person
  • Simone E. Pitts (FDA Associated Person)
View Company Profile

ID · dd9b5ada-6b05-41bf-9251-2b32a99ff4fc

Inspection Facts

Voluntary Action Indicated (VAI)

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

Inspection number
1004513
FDA center
Biologics
Project area
Blood and Blood Products
Outcome
Form 483 issued

Other FDA inspections of Diagnostic Grifols, S.A.

5
DateClassificationOfficeProject area
May 9, 2025Not classifiedOffice of Inspections and Investigations
December 14, 2018NAICenter for Biologics Evaluation and ResearchBlood and Blood Products
July 20, 2017Not classifiedOffice of Inspections and Investigations
February 16, 2017VAICenter for Devices and Radiological HealthCompliance: Devices
January 30, 2015VAICenter for Biologics Evaluation and ResearchBlood and Blood Products
Other documents for Diagnostic Grifols, S.A.
  • FDA Inspection 1273855 - 2025-05-09
  • FDA Inspection 1082479 - 2018-12-14
  • FDA Inspection 1031526 - 2017-07-20
  • FDA Inspection 1002584 - 2017-02-16
  • FDA Inspection 919194 - 2015-01-30

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