FDA 483 - Q-Med AB - March 27, 2026

Q-Med AB in Uppsala, Sweden, a manufacturer of drug substance and drug product, received a Form FDA 483 with 11 observations. The inspection revealed significant deficiencies across contamination control, aseptic processing, environmental monitoring, quality systems, visual inspection, cleaning and disinfection, material control, and laboratory testing. These issues indicate a broad lack of adherence to cGMPs and inadequate quality oversight, posing risks to product quality and sterility.