FDA 483 - Technological Medical Advancements LLC - September 09, 2021

The FDA inspected Technological Medical Advancements LLC in West Palm Beach, FL, identifying 14 observations, many of which are repeat violations from a previous Untitled Letter. The firm demonstrated significant deficiencies across its quality system, including failures in design control, complaint handling, servicing, purchasing, and acceptance activities. Additionally, the company failed to establish procedures for nonconforming product control, quality audits, medical device reporting, management review, and corrective and preventive actions, alongside issues with laser product labeling and annual report submissions.