FDA WARNING_LETTER - Oertel Medical GmbH - January 27, 2012

An FDA inspection of Oertel Medical GmbH in Tuttlingen, Germany, from January 25-27, 2012, revealed that the firm's non-powered endoscopic grasping/cutting instruments are adulterated. The manufacturing methods and controls do not conform to the Quality System regulation, 21 CFR Part 820. The inspection identified 13 significant violations. These include failures to establish and maintain adequate procedures for corrective and preventive actions (21 CFR 820.100(a)), adequately document CAPA activities (21 CFR 820.100(b)), and establish proper complaint handling procedures (21 CFR 820.198(a)). Further deficiencies involved inadequate review and investigation of complaints (21 CFR 820.198(b)), insufficient complaint investigation records (21 CFR 820.198(e)), and a lack of procedures for rework (21 CFR 820.90(b)(2)). The firm also failed to validate computer software (21 CFR 820.70(i)), validate processes (21 CFR 820.75(a)), ensure purchased products conform to requirements (21 CFR 820.50), and control documents (21 CFR 820.40). Additionally, inadequate Device Master Records (21 CFR 820.181(b)), Device History Records (21 CFR 820.184), and training procedures (21 CFR 820.25(b)) were cited. The firm's responses from February 2012 were deemed inadequate as they did not fully address specific deficiencies or provide sufficient evidence of implemented corrections. Oertel Medical must provide a written response within fifteen business days detailing corrective actions, a prevention plan, and a timetable for completion. Failure to comply may result in adverse actions, including impacts on government contracts, device approvals, and Certificates to Foreign Governments.