FDA 483 - CC Wellness, LLC - November 15, 2023

CC Wellness, LLC, a drug product manufacturer in Valencia, CA, was inspected by the FDA and received a Form 483 with five observations. The inspection revealed significant deficiencies in the firm's quality systems, including inadequate written procedures for equipment maintenance and process controls, a failure to conduct thorough investigations into discrepancies, and a lack of annual product reviews. Additionally, the quality control unit's responsibilities and the change control system were found to be insufficient.