FDA 483 - AltaSciences Clinical Los Angeles Inc. - March 24, 2017

WCCT Global, LLC, a Contract Research Organization in Cypress, CA, was cited for significant deviations in clinical investigation conduct. An inspection revealed that an unlisted and untrained physician performed critical end-of-study assessments and signed investigator's signature blocks for multiple subjects. This indicates a failure to adhere to the investigational plan and proper delegation of authority.