FDA 483 - Strides Pharma, Inc. - December 23, 2025

Strides Pharma, Inc. in Chestnut Ridge, NY, was inspected and received a Form 483 with four observations primarily concerning quality control and manufacturing practices. The inspection revealed deficiencies in equipment cleaning validation, microbial method suitability studies, microbiology testing procedures, and equipment calibration documentation. These issues indicate potential risks to drug product quality, identity, strength, and purity.