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Talk to a SpecialistTalk to a SpecialistMectronic Medicale S.R.L., an Italian manufacturer of electronic medical devices including the CHELT, Ixyon XP, iLux Smart, Doctor Tecar, and related product lines, was found to be in violation of FDA's Quality System Regulation (21 CFR Part 820) during an inspection conducted February 24-27, 2025. The company failed to establish and maintain Design History Files (DHFs) for each device type as required by 21 CFR 820.30(j), rendering the devices adulterated under the Federal Food, Drug, and Cosmetic Act. These violations indicated that the firm's manufacturing methods, facilities, and controls did not conform to current good manufacturing practices for medical devices.