FDA EIR - Synexus - Chandler - July 20, 2018

An FDA inspection of Synexus - Chandler, a contract research organization, took place from July 16 to July 20, 2018. This unannounced, directed inspection focused on data integrity for a GDUFA bioequivalent study, falling under the Bioresearch Monitoring regulatory framework (CP 7348.001). The inspection concluded with "No Action Indicated" (NAI), meaning no formal objectionable conditions were found, and no FDA Form 483 (Inspectional Observations) was issued. During the audit, the investigator reviewed extensive study documentation, including source data, case report forms, adverse events, protocol deviations, and informed consents. While no significant discrepancies were identified when comparing the firm's records with those provided by the Center for Drug Evaluation and Research, two minor issues were highlighted. Management was advised to improve the legibility of documentation and refine the process for investigational product reconciliation. At the closeout meeting, Synexus - Chandler was formally reminded of its responsibility to maintain compliance with the Federal Food, Drug, and Cosmetic Act. Both the Site Director and the Principal Investigator acknowledged this warning and committed to ongoing adherence, with efforts already underway to enhance documentation practices and implement quality assurance checks.