FDA EIR - Accellab - July 26, 2012

An FDA inspection of AccelLab, Inc., a preclinical contract research organization in Boisbriand, Canada, was conducted from July 23-26, 2012. This initial inspection focused on Good Laboratory Practices (GLP) for a nonclinical study involving an iliac stent, guided by Compliance Program 7348.808 and 21 CFR Part 58. While no significant regulatory discrepancies resulted in an FDA Form 483, several verbal observations were made. Key issues included delays in signing job descriptions and inadequate Standard Operating Procedures (SOPs) for assigning and replacing study directors, along with insufficient documentation of study director absences. The inspection also noted a failure to retain reserve samples for medical devices in an ongoing study, and that a quantitative angiography software was not fully validated for all relevant diameters prior to use in a completed study. Furthermore, animal facility water quality exceeded specifications in one parameter, and archiving procedures lacked complete documentation, such as archivist initials on log forms and an access log for the archive room. AccelLab management acknowledged these observations and committed to corrective actions. These included improving documentation for training records and study director assignments, updating SOPs for water quality and archiving, ensuring proper retention of reserve device samples, and reviewing software validation procedures. The firm promptly provided draft updated SOPs for study director responsibilities, water sampling, and archiving during the inspection.