FDA 483 - Altasciences Preclinical Seattle, LLC - November 20, 2009

SNBL USA Ltd, a nonclinical laboratory testing facility in Everett, WA, was cited for multiple deficiencies during an FDA inspection from November 16-20, 2009. The firm failed to implement corrective actions from a prior inspection, particularly concerning the use of unsigned draft reports in final studies. Significant issues were also noted in data integrity, equipment calibration, and the overall effectiveness of the quality assurance unit in ensuring compliance with protocols and SOPs.