FDA 483 - Syntho Pharmaceuticals, Inc. - March 01, 2024

Syntho Pharmaceuticals, Inc. received a Form 483 detailing significant deficiencies in its manufacturing and quality control operations for both potent hormone and OTC drug products. The observations highlight a systemic lack of quality unit oversight, inadequate validation of analytical methods and cleaning procedures, and failures in equipment qualification, process validation, and data integrity controls. These issues raise concerns about the identity, strength, quality, and purity of drug products manufactured and distributed by the firm.