483
Appco Pharma, LLCFDA 483 - Appco Pharma, LLC - April 15, 2019
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Record Details
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.
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ID · 0fb91feb-b975-4775-8e58-7aab32f3443e