# FDA 483 - New Wave Endo-Surgical, Corp. - February 17, 2023

Source: https://www.keypedia.com/records/483/new-wave-endo-surgical-corp/caa647cc-0995-4592-b314-c854fb1fc655

> FDA 483 for New Wave Endo-Surgical, Corp. on February 17, 2023. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: New Wave Endo-Surgical, Corp.
- Inspection Date: 2023-02-17
- Product Type: device
- Office Name: Office of Medical Device and Radiological Health Division II
- Summary: An FDA inspection of New Wave Endo-Surgical, Corp. in Coconut Creek, FL, a manufacturer of the M-Close device, revealed significant deficiencies across its quality system. The firm failed to adequately establish and implement procedures for complaint handling, corrective and preventive actions, control of nonconforming product, supplier control, and design changes. These issues indicate a systemic breakdown in maintaining quality and regulatory compliance for their medical devices.

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## Related Officers

- [investigator](https://www.keypedia.com/people/karen-m-rodriguez/fcef1f49-583d-45ab-80e2-4c34793fd722)

Company: https://www.keypedia.com/companies/new-wave-endo-surgical-corp/1c6235ff-0506-4df6-be94-ad51b38aa65d

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