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Regulatory

Baltimore, MD (Camden Campus) Regulatory Inspections

As a contract manufacturer of sterile injectable products, Emergent BioSolutions hosts general inspections by the U.S. FDA on an annual basis. Our CMO business also produces products that are distributed internationally, prompting inspections and approvals by foreign regulatory agencies.

Below is a list of the inspections completed at our Camden Campus located in Baltimore, MD:
 

DATE

INSPECTION COMPLETED

Aug 2015

FDA – CDER (General)

Aug 2015

HPRA (Ireland) Inspection

Nov 2014

HPRA (Ireland) Inspection

Aug 2014

FDA CDER-Directed Inspection (1 product)

Jun 2014

Libya Inspection

Mar 2014

FDA-CDER-General

Aug 2013 

Turkey Inspection

Jun 2013 

GCC (Middle East) Inspection

May 2013 

FDA CBER—1 Pre-Approval Inspection

Mar 2013 

Netherlands Inspection

Feb 2013 

Belarus Inspection

Jul 2012 

FDA CDER—General

Mar 2012 

MPA Inspection—General

Oct 2011 

BMGS (Germany)—General, Post Market

Jul 2011 

FDA CDER/CDRH—General

Jun 2011 

ANVISA Inspection

Mar 2011 

GCC (Middle East) Inspection

Aug 2010 

FDA CBER/CDER/CDRH—General, Post Market

Jun 2010 

MPA Inspection

Mar 2010 

ANVISA Inspection

Jan 2010 

BMGS (Germany)—General, Post Market

Oct 2009 

FDA CBER—General, Post Market

Aug 2009 

FDA CDER—General, 1 Pre-Approval Inspection

Jun 2009 

EMEA Inspection

Sep 2008 

FDA CDER—Directed inspection

May 2008 

FDA CDER—1 Pre-Approval Inspection

Dec 2007 

FDA CDER—General, 1 Pre-Approval Inspection

Jul 2007 

BMGS (Germany) Inspection

May 2007 

FDA CDER/CDRH—General

Sep 2006 

PDMA (Japanese) Inspection 

Aug 2006 

EMEA Inspection

Jul 2006 

MHRA Inspection

Mar 2006 

FDA CDER—General, 1 Pre-Approval Inspection, Post Market

Dec 2005 

FDA CDER—2 Pre-Approval Inspections

Oct 2004 

FDA CDER—General, 2 Pre-Approval Inspection, Post Market

Sept 2004 

FDA CBER (Building B)

Jan 2004 

FDA CBER/CDER—1 Pre-Approval Inspection, Post Market

Sept 2003 

EMEA Inspection

Jun 2003 

FDA CBER (Building B)

May 2003 

FDA CDER—Post Market & Biennial

Aug 2002 

EMEA Inspection

Aug 2002 

Health Canada Inspection

Mar 2002 

FDA CDER—Post Market

Jun 2001 

FDA CDER—Post Market

Jun 2000 

EMEA Inspection

Mar 2000 

FDA CDER—1 Pre-Approval Inspection

Nov 1999 

FDA CBER & CDRH—General Inspection

Jul 1998 

FDA Device—1 Pre-Approval Inspection

May 1998 

FDA Establishment license