Fosun Pharma USA Inc. – FDA EIR, Aug 17, 2021

Fosun Pharma USA Inc. underwent an FDA inspection from August 10-17, 2021, primarily evaluating its drug safety reporting practices after product approval. This initial inspection, conducted under guidelines for Postmarketing Adverse Drug Experience (PADE) reporting, aimed to assess compliance with applicable drug regulations. The inspection identified several key issues, documented on a Form FDA-483. Fosun Pharma failed to submit two quarterly and 117 annual drug safety reports within the mandated timeframes since 2018. Furthermore, 84 annual regulatory reports were not submitted within 60 days of their application anniversary dates. Additional concerns raised during discussions included the absence of written procedures for transferring adverse event information received by the legal department to the drug safety unit, and a lack of established processes to ensure the adequate performance of vendor-provided drug safety services. The company was also unable to provide official acknowledgment receipts for submissions made before July 2020. Fosun Pharma's management acknowledged the observations and discussed items, agreeing to provide a written response within 15 business days. The company is expected to implement improved systems and controls to ensure the timely and accurate submission of all required reports, enhance oversight of external vendors, and establish clear internal communication channels for adverse event data.