FDA 483 - AMKS TIME RELEASE LAB, LLC - July 12, 2013

An FDA inspection of AMZE TIME RELEASE LAB, LLC in Paterson, NJ, revealed six significant observations concerning their role as a sponsor of a clinical investigation. The firm failed to submit an Investigational New Drug (IND) application, monitor the study, or maintain adequate records for the investigational product. Additionally, issues were noted with financial disclosure collection and providing proper training to investigators.