# FDA 483 - Curonix LLC - February 15, 2019

Source: https://www.keypedia.com/records/483/curonix-llc/0faf4f2b-08f8-4fd2-875e-f684a254b331

> FDA 483 for Curonix LLC on February 15, 2019. Product: devices. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Curonix LLC
- Inspection Date: 2019-02-15
- Product Type: devices
- Office Name: Office of Medical Device and Radiological Health Operations Central
- Summary: Stimwave Technologies Inc. received an FDA Form 483 following an inspection conducted from January 29 to February 15, 2019, at their Pompano Beach, FL facility. The inspection identified significant issues indicating a lack of adherence to quality system regulations for medical device manufacturers. Key observations included critically deficient complaint handling procedures. The company failed to adequately receive, review, and evaluate product complaints, particularly regarding returned devices and software-related performance issues. Instances of delayed reporting of adverse events, such as device migration and infections, to the Quality Department and subsequent Medical Device Report (MDR) submissions were noted. Furthermore, field complaint records were not consistently maintained, hindering comprehensive assessment. The FDA also observed inadequacies in corrective and preventive action (CAPA) procedures. Stimwave Technologies lacked systematic analysis of quality data, including returned products and software problems, to identify recurring issues. Design change processes were found insufficient, lacking proper validation or verification for all modifications and specific software changes. Lastly, rework procedures for nonconforming products were not adequately established or implemented, with concerns raised about component traceability and the impact of rework on product life expectancy without proper studies. These observations highlight the need for Stimwave Technologies to implement robust quality system improvements across complaint management, CAPA, design control, and manufacturing rework practices to ensure compliance with federal medical device regulations.

## Related Documents

- [483 - 2019-02-15](https://www.keypedia.com/records/483/curonix-llc/4ea8cdeb-137b-4ae5-ac59-344123fb9c2e)
- [483 - 2022-06-24](https://www.keypedia.com/records/483/curonix-llc/dc6449e0-b46e-4e76-9814-b4a8eadfc16e)
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- [483 - 2023-11-08](https://www.keypedia.com/records/483/curonix-llc/409c4b03-659d-47f9-aad7-42b022008933)

## Related Officers

- [David M. Wilkinson](https://www.keypedia.com/people/david-m-wilkinson/5e81ba03-7602-46d6-b675-26efc77d28db)
- [Chief Executive Officer](https://www.keypedia.com/people/laura-g-perryman/f4c97b91-43ac-44db-afec-d4f2ee99988e)
- [investigator](https://www.keypedia.com/people/karen-m-rodriguez/fcef1f49-583d-45ab-80e2-4c34793fd722)

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-operations-central/fdd6d0ca-6039-4ac5-8989-2b0514b056f0