# FDA 483 - Curonix LLC - June 24, 2022

Source: https://www.keypedia.com/records/483/curonix-llc/dc6449e0-b46e-4e76-9814-b4a8eadfc16e

> FDA 483 for Curonix LLC on June 24, 2022. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Curonix LLC
- Inspection Date: 2022-06-24
- Product Type: device
- Office Name: Office of Medical Device and Radiological Health Division II
- Summary: Stimwave Technologies, Incorporated, a medical device manufacturer in Pompano Beach, FL, was cited for three significant quality system deficiencies during an FDA inspection. The observations included inadequate corrective and preventive action procedures, particularly concerning a patient shock complaint, and issues with process control for product release. Additionally, the firm failed to adequately establish requirements for supplier evaluation.

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## Related Officers

- [investigator](https://www.keypedia.com/people/stanley-b-eugene/4708f43e-0592-4c24-b276-d9f9092788a3)
- [Ebony D. Sanon](https://www.keypedia.com/people/ebony-d-sanon/703dc125-1019-43d1-9598-1bdc92026e2b)

Company: https://www.keypedia.com/companies/curonix-llc/2840a5e9-814d-410e-a50b-656a3e56e1bd

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