FDA WARNING_LETTER - Meditech Kft. - April 13, 2012

This FDA Warning Letter to Meditech, Kft. in Budapest, Hungary, resulted from an April 2012 inspection that found the firm's blood pressure and ECG monitoring systems adulterated. The devices were manufactured without conformity to the Quality System (QS) regulation, 21 CFR Part 820. The FDA identified 14 violations, including inadequate procedures for design changes (21 CFR 820.30(i)), design reviews (21 CFR 820.30(e)), corrective and preventive actions (21 CFR 820.100), and control/disposition of nonconforming product (21 CFR 820.90(a), (b)). Further deficiencies involved purchasing controls (21 CFR 820.50), comprehensive complaint handling (21 CFR 820.198(a)-(e)), document control (21 CFR 820.40), device history records (21 CFR 820.184), and equipment calibration (21 CFR 820.72(a)). The firm's responses to the FDA 483 were largely inadequate, lacking evidence of implemented procedures, approval, training, or retrospective investigations. One CAPA violation was a repeat observation. Consequently, Meditech's devices are subject to refusal of admission into the U.S. (detention without physical examination). The firm must respond within fifteen business days with specific, documented corrective actions, prevention plans, and a timetable, including systemic corrections and retrospective reviews. Uncorrected violations will affect premarket approvals and Certificates to Foreign Governments.