FDA 483 - Appco Pharma, LLC - April 15, 2019

Appco Pharma, LLC in Somerset, NJ was inspected by the FDA from April 8-15, 2019. The inspection revealed a significant issue with the timely submission of periodic adverse drug experience reports (PADERs). Specifically, the firm failed to submit sixteen quarterly PADERs within the required 30-day timeframe.