483
Appco Pharma LLCFDA 483 - Appco Pharma LLC - March 11, 2024
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Record Details
Appco Pharma LLC, a corporate headquarters in Piscataway, NJ, was cited for significant deficiencies in its post-marketing adverse drug experience reporting system. The firm failed to investigate approximately 304 initial 15-day Alert reports and lacked adequate written procedures for the surveillance, receipt, and evaluation of adverse drug experiences. These issues indicate a serious breakdown in their pharmacovigilance processes.
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ID · 1b46e495-7d63-4606-8eea-c099ef180959