FDA EIR - Sinclair Research Center Inc - September 12, 2014

An FDA Good Laboratory Practice (GLP) surveillance inspection was conducted at Sinclair Research Center Inc. from September 8 to September 12, 2014. The inspection, performed under Compliance Program 7348.808 for Nonclinical Laboratories, aimed to assess the contract research organization's adherence to GLP regulations.The primary finding, documented on a one-item Form FDA 483, highlighted that "testing facility management failed to assure that all personnel clearly understood the functions they were to perform." This observation stemmed from a specific incident where a study director electronically submitted a Final Study Report (FSR) to a sponsor in a PDF format that corrupted embedded links, resulting in "Error! Reference source not found" messages throughout the document. This issue indicated a deficiency in personnel understanding of appropriate electronic submission procedures, contrary to 21 CFR 58.31(e) concerning management responsibilities.In response, Sinclair Research Center's management, led by Dr. Jason J. Liu, Vice President of Research, committed to thoroughly investigate the formatting error, identify the root cause of the broken links, and implement corrective and preventive actions (CAPA) to prevent recurrence. The company also indicated plans to contact the affected sponsor for clarification. Additionally, management was advised to submit a formal response to the FDA 483 within 15 days and was reminded of its ongoing responsibility to comply with the Federal Food, Drug, and Cosmetic (FD&C) Act, with potential enforcement actions for non-compliance.