Regulatory Profile
  Chesapeake Biological Laboratories, 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:

May 1998 Establishment license
Jul 1998 Device PAI
Nov 1999 CBER & CDRH - General Inspection
Mar 2000 CDER PAI's
Jun 2000 EMEA Inspection
Jun 2001 CDER - PMI
Mar 2002 CDER - PMI
Aug 2002 Health Canada Inspection
Aug 2002 EMEA Inspection
May 2003 CDER - PMI & Biennial
Jun 2003 CBER (Building B)
Sep 2003 EMEA Inspection
Jan 2004 CBER/CDER - PAI, 3 PMI's
Sep 2004 CBER (Building B)
Oct 2004 CDER - General, 2 PAI's, various PMI's
Dec 2005 CDER - 2 PAI's
Mar 2006 CDER - General, 1 PAI, various PMI's
Jul 2006 MHRA Inspection
Aug 2006 EMEA Inspection
Sep 2006 PDMA (Japanese) Inspection
May 2007 CDER/CDRH - General
July 2007 BMGS (Germany) Inspection

 

 

   
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