FDA WARNING_LETTER - Riverpoint Medical, LLC - February 04, 2013

On January 25, 2013, an FDA inspection of Riverpoint Medical in Portland, Oregon, revealed that their manufactured devices (sutures, biopsy needles, brachytherapy needles, surgical lighting) were adulterated under section 501(h) of the Federal Food, Drug, and Cosmetic Act. The manufacturing, packing, storage, or installation methods and controls did not conform to Current Good Manufacturing Practice (CGMP) requirements of the Quality System (QS) regulation (21 CFR Part 820).

Key violations included: 1. **Failure to adequately document corrective and preventive action (CAPA) activities and results (21 CFR 820.100(b))**: Examples cited were CAPA #020-2011 lacking verification/validation documentation, CAPA #017-2011's required monitoring not conducted, and CAPA #013-2011 lacking documented verification of corrective action. The firm's response was deemed inadequate due to missing documentation. 2. **Failure to establish procedures for receiving, reviewing, and evaluating complaints (21 CFR 820.198(a))**: The Complaint Handling Procedure did not require MedLED™ headlamp deficiencies to be handled as complaints unless under warranty, despite observed issues like exposed wiring. The response was inadequate as it excluded post-warranty returns from complaint handling without justification