FDA 483 - Appco Pharma LLC - March 11, 2024

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.