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.
| 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 |