FDA 483 - Fosun Pharma USA Inc. - August 17, 2021

Fosun Pharma USA Inc. in Princeton, NJ, was inspected from August 10-17, 2021, revealing significant issues with regulatory reporting. The firm failed to timely submit numerous quarterly and annual periodic adverse drug experience reports, as well as general annual reports for various Abbreviated New Drug Applications since 2018. These failures indicate a systemic problem with regulatory compliance regarding post-market reporting requirements.