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

Source: https://www.keypedia.com/records/483/technological-medical-advancements-llc/d28461c0-39f2-40bf-84b7-e885c5c3671b

> FDA 483 for Technological Medical Advancements LLC on April 21, 2025. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Technological Medical Advancements LLC
- Inspection Date: 2025-04-21
- Product Type: device
- Office Name: Florida District Office
- Summary: 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.

## Related Documents

- [483 - 2020-02-24](https://www.keypedia.com/records/483/technological-medical-advancements-llc/2a76e0e0-f542-4be3-b0a4-ccd7f1236a6c)
- [483 - 2021-09-09](https://www.keypedia.com/records/483/technological-medical-advancements-llc/269e0346-13e9-4df5-af02-949c7d635fca)
- [WARNING_LETTER - 2025-04-21](https://www.keypedia.com/records/warning_letter/technological-medical-advancements-llc/ce068041-9110-459f-8c87-71f6d4e26b57)

## Related Officers

- [David M. Wilkinson](https://www.keypedia.com/people/david-m-wilkinson/5e81ba03-7602-46d6-b675-26efc77d28db)
- [Alex J. Wild](https://www.keypedia.com/people/alex-j-wild/bb1b66b3-19b9-480e-af0b-f06f8de0d930)

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

Office: https://www.keypedia.com/offices/florida-district-office/95b2a118-0b78-46e0-a54c-982bd7ce51c9