# FDA 483 - New Wave Endo-Surgical, Corp. - October 28, 2025

Source: https://www.keypedia.com/records/483/new-wave-endo-surgical-corp/fa613afc-fe83-4ec8-9d7b-9535bb16d6b0

> FDA 483 for New Wave Endo-Surgical, Corp. on October 28, 2025. Product: devices. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: New Wave Endo-Surgical, Corp.
- Inspection Date: 2025-10-28
- Product Type: devices
- Office Name: Florida District Office
- Summary: During an FDA inspection conducted from October 22-28, 2025, New Wave Endo-Surgical, Corp. was cited for significant deficiencies in its corrective and preventive action (CAPA) activities and documentation. The primary observation highlighted that the company failed to adequately implement its CAPA procedure, SOP-0020, leading to several procedural lapses.

Specifically, the firm closed CAPAs prematurely without fully verifying their effectiveness, such as CAPA-0007. Other instances included substantial delays in completing CAPA phases without proper justification, as seen with CAPA-0009. Furthermore, essential due dates for CAPA phases were frequently omitted, exemplified by CAPA-0010. A notable issue involved CAPA-0012, which was initiated to address a lack of sufficient manpower but was later disapproved despite the company having taken corrective action by hiring additional staff. These findings indicate a systematic failure to adhere to internal quality system requirements for managing nonconformances and preventing their recurrence.

The FDA noted that this inadequate documentation of CAPA activities is a repeat observation from a previous inspection. This signifies a persistent issue within the firm's quality management system. As per the regulatory framework, New Wave Endo-Surgical, Corp. is responsible for undertaking immediate corrective actions, conducting thorough internal self-audits, and ensuring comprehensive compliance with all quality system requirements to address these critical findings and prevent future recurrences.

## Related Documents

- [483 - 2023-02-17](https://www.keypedia.com/records/483/new-wave-endo-surgical-corp/caa647cc-0995-4592-b314-c854fb1fc655)

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

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