483
Mylan, Inc. A Viatris CompanyMylan, Inc. A Viatris Company – FDA 483, Dec 12, 2025
Record Details
Mylan Inc., A Viatris Company, located in Canonsburg, PA, was inspected regarding a clinical study. The inspection revealed that the firm failed to include required safety information, specifically SUSARS, SAEs, and details of subject withdrawals, in their IND annual reports and amendments. This indicates a significant deficiency in their clinical trial reporting practices.
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ID · 1744c642-c3c6-4602-b6c5-6684d02daadb
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