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

During an inspection conducted from August 26-28, 2025, the U.S. Food and Drug Administration (FDA) issued a Form 483 to Crescent Marketing Inc., a manufacturer of over-the-counter (OTC) products located in North Collins, NY. The inspection revealed significant deviations from Current Good Manufacturing Practices (cGMP) regulations.

Key observations included the absence of a designated quality control unit with proper procedures and authority, leading to product release without adequate quality review. The firm also lacked established written procedures for in-process controls, and electronic records failed to meet integrity requirements, exhibiting vulnerabilities like unprotected data transposition, lack of backup, and insufficient access controls for analytical systems. Furthermore, sanitation practices were inadequate; cleaning procedures between different product types on manufacturing lines did not ensure complete contamination removal or validated cleaning. Finally, employee training in cGMP was deficient, with key personnel in quality and laboratory roles lacking up-to-date or documented competency records.

Crescent Marketing Inc. is required to address these findings by implementing comprehensive corrective actions to establish a robust quality system, ensure data integrity, validate cleaning procedures, and provide ongoing cGMP training for all relevant staff to ensure compliance with federal regulations.