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•United States

Cangene BioPharma, LLC, Rockville, MD – FDA Inspections

Inspection records and compliance data for Cangene BioPharma, LLC in Rockville, Maryland. 3 FDA inspections on record, 2 Form 483s, 1 warning letter, last inspected February 16, 2019.

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Company Profile

This profile covers Cangene BioPharma, LLC based in Rockville, Maryland, United States.

FDA Inspection History

FDA inspections
3
OAI
0
VAI
3
NAI
0
Form 483s
2
Warning letters
1

First inspected April 17, 2015. Last inspected February 16, 2019.

FDA inspections (3)

DateResultFDA center(s)Insp. #
February 16, 2019VAIBiologics · Vaccines and Allergenic Products1084658
March 22, 2017VAIBiologics · Vaccines and Allergenic Products1012266
April 17, 2015VAIBiologics · Vaccines and Allergenic Products928289
FDA documents

Form 483s (1)

  • Form 483s

Warning Letters (1)

  • Warning Letters · February 18, 2022

EIRs (3)

  • EIRs · May 10, 2019
  • EIRs · February 16, 2019
  • EIRs · June 13, 2018
People (4)
Gene D. Arcy
Person
John Decote
Person
Jason Zoldus
Person
Henry Schea
Person
Related Companies (10)

Companies with similar regulatory profiles, compliance history, and operations.

Novartis Gene Therapies, Inc.
Biovex, Inc.
Lux Therapeutics LLC
Abington Memorial Hospital
Wayne Farnsworth, MD
Chara Biologics, Inc.
Xo Biologix
Octapharma Plasma, Inc.
Ultragenyx Pharmaceutical Inc.
Hemacare Corp
Company Information

Name

Cangene BioPharma, LLC

FEI Number

3008934776

Address

9920 Medical Center Dr, Rockville, Maryland 20850-3447, United States

Country

United States

ID: d685e3d6-8e3c-4950-b2f9-9b3aaea0df9d

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