483
Fosun Pharma USA Inc.Fosun Pharma USA Inc. – FDA 483, Aug 17, 2021
Record Details
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.
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