Inspections

Our products and processes have been certified by the FDA, EMEA and other international regulatory authorities for more than 15 years. These inspections ensure a high standard of application security and patient friendliness.

Official inspections - country/authority

2008	Ministry of Health & Medical Education, Iran
2007	Ministry of Health, Japan (MHLW) (paper-based)
2006	Ministry of Health, Algeria
2006	BFDA, Taiwan (Bureau of Food and Drug Analysis)
2006	KFDA, South Korea (Korean Food and Drug Administration)
2004, 2006	Ministry of Health, Russia
2004, 2006	ANVISA Brazil
2004/2005/2008	Ministry of Health, Mexico
1996/2002/2005	Health Canada
2001	Ministry of Health, Saudi Arabia
1996	BSI (British Standard Insitution)
1996/2006	Paul-Ehrlich-Institute
1989/1993	MDD (Medical Device Directorate)
Yearly inspection (last 2007)	Regierungspraesidium Tuebingen

Official inspections - FDA audits

2007	1x GMP (Ravensburg site)
2005	1x GMP (Ravensburg and Langenargen sites) 1x Pre-approval audit ORA
2004	1x GMP audit (CBER/ORA)
2003	1x Pre-approval audit (CBER/ORA) Langenargen
2002-2003	2 x Pre-approval audit (CBER)
2002	1 x GMP audit - Team Biologic / ORA
2001	2 x GMP audit (Langenargen and Ravensburg sites) 4 x Pre-approval audit (CDER)
1990-2000	6 x Pre-approval audit (CDER)
1988-1997	2 x GMP audit (CDER)