FDA 483 - Image Supply Inc - January 08, 2025

Image Supply Inc. in Lumberton, NC, received a Form 483 with six observations during an inspection from January 6-8, 2025. The inspection revealed significant deficiencies in the firm's quality control unit, equipment cleaning and maintenance, stability data for expiration dates, production and process controls, labeling procedures, and employee training in cGMP. These issues indicate a broad lack of adherence to good manufacturing practices for drug products.