Compliance track record
Inspections carried out to date.
Inspections Zofingen, Switzerland (since 2000) | ||
Swissmedic | Mar 2000 | GMP Certificate |
Swissmedic | Nov 2001 | GMP Certificate |
Swissmedic | Nov 2002 | GMP Certificate |
Swissmedic | Dec 2002 | GMP Certificate |
FDA | Jun 2003 | No Action Indicated |
Swissmedic | Feb 2004 | GMP Certificate |
Swissmedic | Nov 2004 | GMP Certificate |
FDA | Aug 2006 | No Action Indicated |
Swissmedic | Nov 2006 | GMP Certificate |
Swissmedic | Dec 2006 | GMP Certificate |
Swissmedic | Feb 2007 | GMP Certificate |
Swissmedic | Jun 2007 | GMP Certificate |
FDA | Nov 2007 | No Action Indicated |
FDA | Jul 2008 | No Action Indicated |
Swissmedic | Apr 2009 | GMP Certificate |
Swissmedic | Aug 2009 | GMP Certificate |
Swissmedic | Oct 2009 | GMP Certificate |
FDA | Jul 2010 | No Action Indicated |
Swissmedic | Feb 2011 | GMP Certificate |
Korea FDA | Feb 2011 | No Action Indicated |
Swissmedic | Aug 2011 | GMP Certificate |
|
|
|
Other |
|
|
ANVISA | Sep 2002 | GMP Certificate |
Customer audits | approx. 50 audits/year |
|
Inspections Pennsville, USA | ||
FDA | Sep 2002 | No Action Indicated |
FDA | Jun 2003 | No Action Indicated |
FDA | Sep 2004 | No Action Indicated |
FDA | Jun 2006 | No Action Indicated |
FDA | Dec 2007 | No Action Indicated |
FDA | Dec 2008 | No Action Indicated |
FDA | May 2009 | No Action Indicated |
Japanese-PMDA | Nov 2009 | Accreditation Certificate |
Korean FDA | Jun 2010 | No Action Indicated |
FDA | Mar 2011 | No Action Indicated |
Inspections Malta | ||
Maltese Authorities | Nov 2006 | GMP Certificate |
Maltese Authorities | Apr 2008 | GMP Certificate |
Maltese Authorities | Mar 2010 | GMP Certificate |
FDA | Mar 2011 | No Action Indicated |