FDA 483 - Crescent Marketing, Inc. dba Crescent Mfg - August 28, 2025
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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.
ID · e5a0384d-0fe1-4402-b9e8-27ce2ac04394