FDA 483 - RISING PHARMACEUTICALS INC - January 28, 2019

An FDA inspection of Rising Pharmaceuticals Inc. in Saddle Brook, NJ, revealed a significant issue regarding the timely submission of periodic adverse drug experience reports. The firm failed to submit required quarterly reports for cevimeline hydrochloride (ANDA# 203775) for multiple reporting periods in 2016 and 2017. This indicates a non-compliance with drug safety reporting requirements.