FDA 483 - Crescent Marketing, Inc. dba Crescent Mfg - August 28, 2025

Crescent Marketing Inc., a manufacturer of OTC products in North Collins, NY, was cited for significant cGMP deficiencies during an FDA inspection. The firm lacks a designated quality control unit, has inadequate data integrity controls for analytical data, and fails to properly sanitize equipment or validate cleaning procedures to prevent cross-contamination. Additionally, employees, including key quality and manufacturing personnel, lack adequate and up-to-date GMP training.