FDA 483 - NAMSA - February 18, 2008

An FDA inspection of Biomatech, SAS, a contract testing laboratory in Chasse-sur-Rhone, France, revealed significant quality system deficiencies. The firm failed to complete out-of-specification investigations before reporting results, maintain adequate testing documentation, and properly investigate unexpected animal deaths. Additionally, issues were noted with computer system controls and the establishment of variance limits for testing parameters.