Nephros, Inc. – FDA Warning Letter, Oct 24, 2014

On May 27, 2015, the FDA issued a Warning Letter to Nephros Inc. following an inspection from October 8-24, 2014, which revealed violations of the Quality System (QS) regulation (21 CFR Part 820) for medical devices including Dual Stage Ultrafilter (DSU) and OLpur Hemodiafiltration Systems. The devices were deemed adulterated under Section 501(h) of the Act.

Key violations included: 1. **Failure to document supplier evaluation (21 CFR 820.50(a)(1))**: Nephros Inc. did not adequately evaluate all active suppliers, including those for sterilization, dialyzers, and dialysis equipment. Previous inspections also noted purchasing control deficiencies. The firm's corrective actions (CAPA 13-014, 14-030, SOP 7.4 revision) were deemed inadequate, as the FDA emphasized the firm's responsibility for oversight of all manufacturing operations, even those contracted out. 2. **Inadequate complaint investigation records (21 CFR 820.198(e))**: Complaint investigations for devices like the DSU, SSU, and OLpur H2H Hemodiafiltration Module lacked critical information such as label reviews, inventory analysis, and trend analysis, despite the firm's SOP 8.2.1. Prior inspections