NorMedMay 29, 2025

FDA 483 - NorMed - May 29, 2025

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Record Details

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.

Company: NorMed
Inspection Date: May 29, 2025
Product Type: Drugs
Office: Seattle District Office
People: Christopher R. Czajka (Consumer Safety Officer (Inspector))
Aranjeet Singh (FDA_PERSONNEL)
Thuy Tram L. Nguyen

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ID · dbdc1276-6942-4a69-9b02-33b7603df1b9