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Deymed Diagnostic s.r.o., a Czech manufacturer of Class II medical devices including BrainFeedback Pro, TruScan LT, and DuoMAG NL, was cited for failing to comply with current good manufacturing practice (CGMP) requirements under 21 CFR Part 820. During a July 2023 inspection, the FDA identified that the company's manufacturing methods, facilities, and controls were inadequate, with specific violations including failure to establish and maintain proper design control procedures as required by 21 CFR 820.30(a). The company's devices were determined to be adulterated due to these Quality System regulation deficiencies.