FDA 483 - Buckeye International Inc - June 04, 2021

Agnitio Inc. in Appleton, WI, was inspected by the FDA from June 1-4, 2021, and received a Form FDA 483. The inspection revealed that the firm failed to follow its written stability program, specifically regarding the review and verification of stability data for Triamterene Capsules 50 mg USP. This indicates a lapse in quality unit oversight concerning product stability.