FDA 483 - NorMed - May 29, 2025

NorMed, a drug repacker in Tukwila, WA, received a Form FDA 483 with two repeat observations during an inspection. The firm failed to validate the reliability of component supplier analyses for its own-label OTC drug products. Additionally, drug products were not stored under appropriate temperature and humidity conditions, and environmental monitoring and device calibration were found to be inadequate.