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

Source: https://www.keypedia.com/records/483/technological-medical-advancements-llc/269e0346-13e9-4df5-af02-949c7d635fca

> FDA 483 for Technological Medical Advancements LLC on September 09, 2021. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Technological Medical Advancements LLC
- Inspection Date: 2021-09-09
- Product Type: device
- Office Name: Office of Medical Device and Radiological Health Division II
- Summary: 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.

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## Related Officers

- [David M. Wilkinson](https://www.keypedia.com/people/david-m-wilkinson/5e81ba03-7602-46d6-b675-26efc77d28db)

Company: https://www.keypedia.com/companies/technological-medical-advancements-llc/35a6daf9-3683-4870-8f44-07a02dbfa2c5

Office: https://www.keypedia.com/offices/office-of-medical-device-and-radiological-health-division-ii/ae9bd439-479a-420d-9dd8-9fe1fc0863d6