# FDA 483 - Curonix LLC - November 08, 2023

Source: https://www.keypedia.com/records/483/curonix-llc/409c4b03-659d-47f9-aad7-42b022008933

> FDA 483 for Curonix LLC on November 08, 2023. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Curonix LLC
- Inspection Date: 2023-11-08
- Product Type: device
- Office Name: Office of Medical Device and Radiological Health Division II
- Summary: Curonix LLC, a medical device manufacturer in Pompano Beach, FL, was cited for significant deficiencies in its quality system during an FDA inspection. The firm failed to adequately establish procedures for corrective and preventive actions, complaint handling, software validation, and the disposition of nonconforming products. These issues led to the distribution of mislabeled stimulators and a subsequent market withdrawal.

## Related Documents

- [483 - 2019-02-15](https://www.keypedia.com/records/483/curonix-llc/0faf4f2b-08f8-4fd2-875e-f684a254b331)
- [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)
- [483 - 2023-11-08](https://www.keypedia.com/records/483/curonix-llc/1010fbc1-7a19-4746-aafd-6a58d7003913)

## Related Officers

- [Dianiris C. Ayala](https://www.keypedia.com/people/dianiris-c-ayala/ba6c5538-201b-4c9a-8f23-e160db6868e6)

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