FDA EIR - Esoterix Clinical Trials Services - June 27, 2018

An FDA inspection was conducted at Esoterix Clinical Trials Services in Englewood, CO, from June 13 to June 27, 2018. This pre-announced data integrity inspection was performed under Compliance Program 7348.001 (Bio-Analytical In-Vivo BA/BE), focusing on a limited institution pilot study. The inspection revealed several objectionable conditions, resulting in the issuance of an FDA-483, Inspectional Observations, to the company's Technical Director.

Key violations included the failure to update analysis results with corrected numerical values after an error was discovered in reporting a specific parameter. Specifically, a database of analysis results did not reflect the necessary updates, and final corrected values were not provided to the study sponsor. Additionally, the company did not adequately maintain study correspondence, which hindered the reconstruction of study events. A contributing factor to this issue was the absence of a formalized site-specific procedure requiring the maintenance of internal and external communications related to clinical trial work.

In response to these findings, Esoterix Clinical Trials Services was required to address the FDA-483 observations in writing within 15 days. The firm's response was subsequently submitted. The company was also reminded of its ongoing responsibility to comply with the Federal Food, Drug, and Cosmetic Act to avoid potential penalties for non-compliance.