FDA EIR - Convatec Inc. - April 16, 2014

A follow-up FDA inspection of Convatec Inc.'s Skillman, NJ facility was conducted from March 10 to April 16, 2014. The inspection aimed to assess corrective actions stemming from a previous FDA-483 and Warning Letter issued in 2013, which highlighted deficiencies in Corrective and Preventive Actions (CAPA) implementation, Medical Device Reporting (MDR) evaluation and submission, and inadequate design change verification. The prior findings had led to an Official Action Indicated (OAI) classification.The current inspection, which included a comprehensive review of management, CAPA, design, purchasing, and production controls, found that the firm's corrections to the previous violations were largely inadequate or incomplete. Significant issues persisted, including deficiencies in the evaluation and investigation of MDR reportable complaints, design verification and validation for the Flexi-Seal CONTROL fecal management system, and late or incomplete submission of MDRs. A key finding was the determination by FDA's CDRH that Convatec's Flexi-Seal CONTROL device required 510(k) clearance, which the company had not obtained. Consequently, an FDA-483 was issued, listing six repeat and three new objectionable conditions. In response, Convatec Inc. initiated a voluntary recall for all US-distributed Flexi-Seal CONTROL devices and committed to providing a written response to the FDA's observations within 15 days.