FDA WARNING_LETTER - Osypka Medical Gmbh - December 01, 2011

An FDA inspection of Osypka Medical GmbH in Berlin, Germany, from November 28 to December 1, 2011, revealed that the firm's external pacemakers and cardiac monitoring devices are adulterated and misbranded. The devices are adulterated under 21 U.S.C. § 351(h) because manufacturing methods and controls do not conform to the Quality System regulation (21 CFR Part 820). Specific QS violations include inadequate procedures for design changes (21 CFR 820.30(i)), corrective and preventative actions (21 CFR 820.100(a)(1)), complaint handling (21 CFR 820.198(a)), and quality audits (21 CFR 820.22). Additionally, the firm failed to promptly remove obsolete documents (21 CFR 820.40(a)). The devices are also misbranded under 21 U.S.C. § 352(t)(2) due to the firm's failure to develop, maintain, and implement written Medical Device Reporting (MDR) procedures as required by 21 CFR 803.17. The firm's responses to the FDA 483 observations were deemed largely inadequate, lacking documentation of implemented corrective actions or systemic changes. Osypka Medical GmbH must provide a written response within fifteen business days detailing specific corrections, preventative measures, and a timetable for implementation. Failure to correct these violations will impact premarket approvals for Class III devices and Certificates to Foreign Governments.