Quality Management

Audit track records and certification

Food and Drug Administration
 
Omnichem has a long history of good track records with FDA. The 3 sites were in total inspected by the American Authorities 17 times.

Wetteren

Louvain-La-Neuve

Balen

September 1978

September 1983

February 2004

May 1981

February 1986

September 1983

March 1990

February 1986

October 1994

March 1990

February 1998

October 1994

May 2001

February 1997

September 2007

May 2000

November 2004

 
 
  
Other National authorities:
 
 
Regulatory Inspections at Balen : voluntary inspections by MHRA (UK)
 
            9th – 11th April 2003
            17th – 18th October 2005
            GMP certificate available on demand
 
 Regulatory Inspections at Wetteren : voluntary inspections by MHRA (UK)
  
            26th – 28th January 2004
            19th – 21th Oct 2005
            GMP certificate available on demand
 
 
Regulatory Inspections at Louvain-La-Neuve : voluntary inspections
by Belgian Authorities
                    
             17th November 2004
             28th – 29th September 2005
             GMP certificate available on demand