FDA 483 - Athenex, Inc. - July 11, 2019

Athenex, Inc. in Buffalo, NY, a laboratory/corporate headquarters, was cited for failing to adhere to its own written procedures regarding the timely submission and justification of investigation extension forms. Specifically, several Laboratory Investigation Reports were found to be significantly late without proper extensions. This indicates a breakdown in the firm's quality system for managing deviations and investigations.