# FDA 483 - Poiesis Medical, LLC - October 30, 2024

Source: https://www.keypedia.com/records/483/poiesis-medical-llc/003ed4d2-0f16-45f2-9fb4-5613a63fb392

> FDA 483 for Poiesis Medical, LLC on October 30, 2024. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Poiesis Medical, LLC
- Inspection Date: 2024-10-30
- Product Type: device
- Office Name: Florida District Office
- Summary: An FDA inspection of Poiesis Medical, LLC in Jupiter, FL, identified a significant lapse in quality system management. The firm failed to conduct and document required management reviews of its quality system at defined intervals, as stipulated by its own procedures. This indicates a fundamental issue with oversight of the quality system's suitability and effectiveness.

## Related Documents

- [EIR - 2024-10-30](https://www.keypedia.com/records/eir/poiesis-medical-llc/5e97d9d4-4f17-463c-939f-edde95f2dadd)

## Related Officers

- [Alex J. Wild](https://www.keypedia.com/people/alex-j-wild/bb1b66b3-19b9-480e-af0b-f06f8de0d930)

Company: https://www.keypedia.com/companies/poiesis-medical-llc/03a8a2d5-3e29-45b1-9b42-c9df9d88ca8e

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