FDA 483 - Biovail Contract Research - October 30, 2009

An FDA inspection of Biovail Contract Research in Toronto, Canada, a biopharmaceutical clinical and bioanalytical facility, revealed significant deficiencies. Observations included failures in retaining study reserve samples, insufficient assessment of incurred sample reproducibility, inadequate pipette calibration procedures, and issues with raw data documentation and accuracy. These findings indicate a need for improved controls in laboratory practices and data management.