FDA WARNING_LETTER - Trokamed GmbH - June 27, 2013

An FDA inspection of Trokamed GmbH in Geisingen, Germany, from June 24-27, 2013, revealed that the firm's manufactured devices, including Intraluminal Artery Strippers and Morcellators, are adulterated. This is due to non-conformity with the Quality System (QS) regulation (21 CFR Part 820). The firm's July 17, 2013, response to the FDA 483 was largely deemed inadequate. Key violations include: failure to establish and maintain procedures for process validation (21 CFR 820.75(a)), with several manufacturing processes remaining unvalidated; failure to validate critical computer software for its intended use (21 CFR 820.70(i)); failure to establish and maintain procedures for the identification, documentation, validation, or verification, review, and approval of design changes before implementation (21 CFR 820.30(i)); failure to establish and maintain procedures to control all required documents (21 CFR 820.40), though the firm's response for this point appeared adequate; and failure to establish and maintain procedures for quality audits conducted by individuals without direct responsibility for audited matters (21 CFR 820.22). The FDA requires Trokamed to provide a written response within fifteen business days detailing specific corrective actions, prevention plans, and a timetable for completion, with supporting documentation. Failure to correct these violations may impact federal contracts, premarket approval for Class III devices, and Certificates to Foreign Governments. The letter emphasizes that these issues may indicate systemic problems in the firm's manufacturing and quality management systems.