FDA 483 - STRIVE PHARMACEUTICALS INC - June 02, 2025

Strive Pharmaceuticals, Inc. in East Brunswick, NJ, received a Form 483 citing issues with equipment design and operation during drug product packaging. The inspection revealed that tablet counting and dispensing equipment was not adequately qualified, leading to underfilled units and product loss. These deficiencies resulted in customer complaints and a lack of assurance regarding accurately filled units.