Citoxlab North America Inc – FDA EIR, Mar 2, 2018

An FDA inspection of Citoxlab North America Inc., a contract research organization located in Laval, Canada, was conducted from February 26 to March 2, 2018. This was a data integrity inspection directed by the Center for Drug Evaluation and Research (CDER) to assess compliance with regulatory standards for drug development studies. The inspection specifically audited one efficacy study and two pharmacokinetic studies, which were conducted on Rhesus monkeys. The scope of the inspection was comprehensive, covering various aspects of the firm's laboratory operations, including organizational structure, personnel qualifications, testing facility procedures, quality assurance unit effectiveness, equipment maintenance and calibration, adherence to Standard Operating Procedures (SOPs), animal care practices, management of test and control articles, study protocols and conduct, and the integrity of records and reports. While a previous inspection in 2013 had resulted in observations related to master schedule accuracy, report finalization, documentation of correspondence, adherence to procedures, and pathologist attribution, the current 2018 inspection concluded without any adverse findings. The FDA inspector did not issue a Form FDA 483, indicating no significant violations were identified. Consequently, the inspection was classified as "No Action Indicated," meaning no regulatory actions or specific required actions were necessitated by this particular inspection. Citoxlab North America Inc. provided timely responses and documentation throughout the process.