FDA 483 - TAGI Pharma, Inc. - June 12, 2025

An FDA inspection of TAGI Pharma, Inc. in South Beloit, IL, revealed a significant issue regarding the timely submission of annual reports for approved drug products. The firm failed to submit these reports within 60 days of the anniversary date for multiple products, including Dexmedetomidine HCl and Methazolamide Tablets, for reporting years 2023, 2024, and 2025. This indicates a lapse in regulatory compliance concerning post-approval reporting requirements.