FDA 483 - Valisure, LLC - July 06, 2021

An FDA inspection of Valisure, LLC in New Haven, CT, an analytical lab, revealed significant deficiencies across multiple quality systems. The firm failed to adequately validate analytical methods, qualify equipment, control data access, and conduct proper laboratory investigations for out-of-specification events. Furthermore, Valisure demonstrated a critical lack of compliance with Drug Supply Chain Security Act requirements for handling suspect and illegitimate products and making timely notifications.