Inspections
Our products and processes have been certified by the FDA, EMA and other international regulatory authorities for more than 20 years. The successful inspections demonstrate that Vetter has the highest quality and security standards when it comes to manufacturing aseptically prefilled injection systems.
Our products and processes have been certified by the FDA, EMA and other international regulatory authorities for more than 20 years. The successful inspections demonstrate that Vetter has the highest quality and security standards when it comes to manufacturing aseptically prefilled injection systems.
Official inspections – country/authority
| 2011, 2010, 2009, 2008, 2005, 2004 | Ministry of Health, Mexico |
| 2011, 2010, 2009, 2006 | BFDA, Taiwan (Bureau of Food and Drug Analysis) |
| 2009 | Gulf Central Committee |
| 2009 | National Drug Authority Uganda |
| 2011, 2009, 2007, 2006, 2004 | ANVISA Brazil |
| 2011, 2009, 2007, 2006 | KFDA, South Korea (Korean Food and Drug Administration) |
| 2009, 2008, 2007 | Pharmaceuticals and Medical Device Agency Japan (paper based) |
| 2008 | Ministry of Health & Medical Education, Iran |
| 2006 | Ministry of Health, Algeria |
| 2006, 2004 | Ministry of Health, Russia |
| 2006, 1996 | Paul-Ehrlich-Institute |
| 2005, 2002, 1996 | Health Canada |
| 2001 | Ministry of Health, Saudi Arabia |
| 1996 | BSI (British Standards Insitution) |
| 1993, 1989 | MDD (Medical Device Directorate) |
| Yearly inspection (last 2010) | Regierungspraesidium Tuebingen |
Official inspections – FDA inspections
| 2010 | 1 x Pre-approval inspection (Ravensburg) |
| 2010, 2008 | 1 x GMP ORA (Ravensburg site - CDER) |
| 2010, 2008 | 1 x GMP ORA (Langenargen site - CDER) |
| 2010, 2008 | 1 x GMP ORA (Ravensburg South site - CDER) |
| 2007 | 1 x GMP (Ravensburg site) |
| 2005 | 1 x GMP (Ravensburg and Langenargen sites) 1 x Pre-approval inspection ORA |
| 2004 | 1 x GMP inspection (CBER/ORA) |
| 2003 | 1 x Pre-approval inspection (CBER/ORA) Langenargen |
| 2002-2003 | 2 x Pre-approval inspection (CBER) |
| 2002 | 1 x GMP inspection – Team Biologic/ORA |
| 2001 | 2 x GMP inspection (Langenargen and Ravensburg sites) 4 x Pre-approval inspection (CDER) |
| 1990-2000 | 6 x Pre-approval inspection (CDER) |
| 1988-1997 | 2 x GMP inspection (CDER) |