FDA WARNING_LETTER - Fresenius Medical Care, North America - December 07, 2012

An FDA inspection of Fresenius Medical Care, North America in Ogden, UT, from November 26 to December 7, 2012, revealed that their Optiflux Polysulfone Dialyzers, classified as medical devices, were adulterated. This adulteration stems from non-conformity with the Quality System regulation (21 CFR Part 820), specifically regarding manufacturing controls. The firm's responses dated December 28, 2012, January 2, 2013, and February 7, 2013, were deemed inadequate by the FDA. Key violations include the failure to establish and maintain adequate procedures for verifying device design, as required by 21 CFR 820.30(f). This was evidenced by incomplete biocompatibility testing, lack of documentation for required additional testing, and insufficient design verification studies. Additionally, the firm failed to establish and maintain adequate procedures for validating device design, as mandated by 21 CFR 820.30(g). Deficiencies included incomplete design validation for Optiflux PS dialyzers, a clinical study conducted too late and not on initial production units, and a Risk Management Matrix that failed to identify all relevant risks. The FDA requires prompt corrective actions. The firm must notify the FDA within fifteen business days with specific steps taken, prevention plans, and supporting documentation. Failure to correct these serious quality system deficiencies may result in regulatory actions such as seizure, injunction, civil money penalties, and impact on federal contracts, premarket approvals, and Certificates to Foreign Governments.