483
RISING PHARMACEUTICALS INCRISING PHARMACEUTICALS INC – FDA 483, Jan 28, 2019
Record Details
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.
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ID · 1c44775e-ded9-4d72-afed-d114de03b523
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