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FDA Inspection
•Kedrion Biopharma Inc.•November 16, 2018

Kedrion Biopharma Inc. – FDA Inspection, Nov 16, 2018

Record Details

This FDA Inspection record concerns Kedrion Biopharma Inc., with an inspection on November 16, 2018, issued by the New York District Office, covering biologics.

Company
Kedrion Biopharma Inc.
Inspection Date
November 16, 2018
Product Type
Biologics
Office
New York District Office
People
  • Bradley J. Dworak
  • Irina Gaberman (FDA Associated Person)
  • Joan Johnson (Investigator)
  • Lu Deng (Issuing Officer)
  • Malgorzata G. Norton (Company Rep)
  • Olga Simakova (Issuing Officer)
View Company Profile

ID · b8e2cc2d-0f5f-43fb-9760-367882106354

Inspection Facts

Inspection number
1079026
FDA center
Biologics
Outcome
Form 483 issued

Other FDA inspections of Kedrion Biopharma Inc.

6
DateClassificationOfficeProject area
March 27, 2024VAICenter for Biologics Evaluation and ResearchBlood and Blood Products
June 25, 2021VAICenter for Biologics Evaluation and ResearchBlood and Blood Products
August 29, 2018VAICenter for Biologics Evaluation and ResearchBlood and Blood Products
September 29, 2014VAICenter for Biologics Evaluation and ResearchBlood and Blood Products
August 2, 2012VAICenter for Biologics Evaluation and ResearchBlood and Blood Products
View all 6 other inspections on the company page
Other documents for Kedrion Biopharma Inc.
  • FDA Inspection 1231467 - 2024-03-27
  • FDA Inspection 1148187 - 2021-06-25
  • FDA Inspection 1064655 - 2018-08-29
  • FDA Inspection 900509 - 2014-09-29
  • FDA Inspection 801013 - 2012-08-02

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Contact
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Scranton Office:
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