FDA WARNING_LETTER - Microsulis Medical Ltd. - July 09, 2009

An FDA inspection of Microsulis Medical Limited in Denmead, UK, from July 6-9, 2009, revealed that the firm's microwave endometrial and tissue ablation devices are adulterated under 21 U.S.C. 351(h). This is due to non-conformity with Current Good Manufacturing Practice (CGMP) requirements of the Quality System (QS) regulation, 21 CFR Part 820. The inspection identified several significant violations. The firm failed to establish and maintain adequate procedures for corrective and preventive actions (21 CFR 820.100(a)), including insufficient analysis of nonconforming products. Complaint handling procedures were inadequate (21 CFR 820.198), as returned products with performance issues were not entered into the complaint system. Deficiencies were also noted in design control, specifically regarding verifying design outputs against input requirements (21 CFR 820.30(f)) and validating device design to user needs and intended uses, including risk analysis (21 CFR 820.30(g)). While the firm's response to a design change procedure violation (21 CFR 820.30(i)) was adequate, procedures for quality audits (21 CFR 820.22) were found insufficient, with critical areas not being audited regularly. The firm's July 23, 2009, response was largely deemed inadequate, lacking specific corrective actions, systemic changes, or supporting documentation. Microsulis must promptly correct these violations and notify the FDA within 15 working days, providing a detailed plan, documentation, and a timetable. Failure to comply could result in device detention, impact on federal contracts, and denial of premarket approvals or Certificates to Foreign Governments. The FDA stressed that these issues may indicate broader systemic problems requiring thorough investigation.