FDA WARNING_LETTER - Generic Medical Devices, Inc. - April 25, 2012

An FDA inspection of GMD in Gig Harbor, Washington, from April 3 to April 25, 2012, found that the firm's Urinary Incontinence Slings (GMD 1011 and GMD 1012) are adulterated and misbranded. The devices are adulterated under 21 U.S.C. § 351(h) due to non-compliance with Quality System (QS) regulation (21 CFR Part 820). QS violations include inadequate procedures for corrective and preventive action, failure to investigate nonconformities, insufficient incoming and finished product acceptance procedures, inadequate data for purchased products/services, and improper supplier evaluation. Deficiencies also covered document review, approval, and change record maintenance. The devices are misbranded under 21 U.S.C. § 352(t)(2) due to Medical Device Reporting (MDR) failures, specifically untimely reporting of serious injuries and inadequate internal systems for identifying and evaluating MDR events, including foreign occurrences. GMD's responses were largely deemed inadequate, lacking evidence of comprehensive corrective actions or timelines. The FDA acknowledged GMD's statement of discontinuing business operations. If operational, GMD must correct all violations within fifteen business days to avoid regulatory actions like seizure, injunction, civil money penalties, and impacts on premarket approvals and Certificates to Foreign Governments. A comprehensive response detailing corrective actions and prevention plans is required.