FDA 483 - Exel Inc. - November 25, 2024

An FDA inspection of Exel Inc. dba DHL Supply Chain (USA) in Lockbourne, OH, revealed multiple significant deficiencies in their quality systems for repackaged OTC drug products. The firm lacked adequate written procedures for production controls, investigations, annual product reviews, labeling, cleaning, and maintenance. These issues indicate a broad failure to adhere to good manufacturing practices, impacting product quality and control.