Arcamed LLC – FDA 483, Sep 21, 2023

Arcamed LLC, a manufacturer in Indianapolis, IN, was inspected by the FDA and received a Form 483. The inspection identified deficiencies in the firm's quality management system, specifically regarding procedures for controlling nonconforming product, corrective and preventive actions (CAPA), and internal quality audits. These observations highlight a lack of adequate documentation and verification processes within their quality system.