FDA WARNING_LETTER - Sorin Group Deutschland GmbH - April 13, 2011

An FDA inspection of Sorin Group Deutschland GmbH in Munchen, Germany, from April 11-13, 2011, found their Stockert S5 System device misbranded under section 502(t)(2) of the Act. The firm failed to furnish required information under section 519, specifically regarding Medical Device Reporting (MDR) (21 CFR Part 803) and Quality System (QS) regulation (21 CFR Part 820) deficiencies. Violations included: failure to develop and implement written MDR procedures (21 CFR 803.17(a)); failure to submit MDRs within 30 days for malfunctions likely to cause death or serious injury (21 CFR 803.50(a)(2)); failure to verify corrective and preventive action effectiveness (21 CFR 820.100(a)(4)); failure to adequately investigate complaints (21 CFR 820.198(c)); failure to maintain adequate procedures for design changes (21 CFR 820.30(i)); failure to verify device design output meets input requirements (21 CFR 820.30(f)); failure to ensure design requirements address intended use (21 CFR 820.30(c)); and failure to validate device design with adequate risk analysis (21 CFR 820.30(g)). The firm's May 4, 2011, response was largely inadequate, lacking documentation or evidence of corrective action effectiveness. Sorin Group must promptly correct these systemic violations. A written response is required within fifteen business days, detailing specific corrective and preventative actions, supporting documentation, and a timetable. Non-compliance could lead to regulatory actions like seizure, injunction, or civil money penalties.