FDA 483 - Technological Medical Advancements LLC - April 21, 2025

An FDA inspection of Technological Medical Advancements LLC, a medical device manufacturer in West Palm Beach, revealed nine significant violations of quality system regulations. The firm failed to establish or adequately follow procedures for design control, complaint handling, purchasing, corrective and preventive actions, quality audits, nonconforming product, and management review. Many of these observations were repeats from previous inspections and an untitled letter, indicating persistent and systemic non-compliance.