483
NAMSAFDA 483 - NAMSA - February 18, 2008
Discuss this record with AI
Document or profile
One record shows the event. A profile shows the pattern.
Buy this document for the source file and details behind this single event.
Choose full profile access to connect related records, sites, people, citations, and enforcement history in one view.
Record Details
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.
Open in Dashboard
ID · 26671a67-13f2-4f89-a817-ea11f9692e5a