Regulatory Profile
  Cangene bioPharma, Inc.

 

As a contract manufacturer of parenteral products, CBL hosts general inspections by the FDA on an annual basis. With the increase in CBL produced products being distributed internationally, inspections and approvals by foreign regulatory agencies, including the MHRA, EMEA, and JPMD have increased as well.

Below is a snapshot of the inspections completed at CBL’s multi-use facility:

Sep-08 CDER - Directed inspection
May-08 CDER - 1 PAI
Dec-07 CDER - General, 1 PAI
Jul-07 BMGS (Germany) Inspection
May-07 CDER/CDRH - General
Sep-06 PDMA (Japanese) Inspection
Aug-06 EMEA Inspection
Jul-06 MHRA Inspection
Mar-06 CDER - General, 1 PAI, various PMI's
Dec-05 CDER - 2 PAI's
Oct-04 CDER - General, 2 PAI's, various PMI's
Sep-04 CBER (Building B)
Jan-04 CBER/CDER - PAI, 3 PMI's
Sep-03 EMEA Inspection
Jun-03 CBER (Building B)
May-03 CDER - PMI & Biennial
Aug-02 EMEA Inspection
Aug-02 Health Canada Inspection
Mar-02 CDER - PMI
Jun-01 CDER-PMI
Jun-00 EMEA Inspection
Mar-00 CDER PAI's
Nov-99 CBER & CDRH - General Inspection
Jul-98 Device PAI, approved
May-98 Establishment license

 

 

   
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