FDA WARNING_LETTER - Conkin Surgical Instruments Ltd. - September 11, 2014

The FDA issued a Warning Letter to Conkin Surgical Instruments Ltd. following an inspection from September 8-11, 2014, in Toronto, Canada. The inspection revealed that the firm's Valtchev Uterine Mobilizer device is adulterated under 21 U.S.C. § 351(h) due to non-conformity with Quality System (QS) regulation (21 CFR Part 820) and misbranded under 21 U.S.C. § 352(t)(2) for failing to provide required Medical Device Reporting (MDR) information (21 CFR Part 803). Key QS violations include failures to establish and maintain procedures for corrective and preventive actions (CAPA), document CAPA results, establish complaint handling procedures (including not recognizing unscheduled repairs as complaints), establish design change procedures, establish incoming and finished product acceptance procedures, document acceptance activities, and control labeling activities. Additionally, the firm failed to develop, maintain, and implement written MDR procedures. The firm's October 3, 2014, response was deemed inadequate as it lacked documentation of immediate corrections and systemic corrective actions. The MDR procedure was also not provided for review. As a result of these serious violations, Valtchev Uterine Mobilizers are subject to refusal of admission into the U.S. (detention without physical examination). The firm must respond within fifteen business days with specific, documented corrective actions addressing systemic problems and a timetable for completion. Failure to correct these issues will impact device entry into the U.S. and potential federal contracts.