# FDA 483 - Onkos Surgical, Inc. - April 04, 2025

Source: https://www.keypedia.com/records/483/onkos-surgical-inc/fa5b44f2-cc5d-43f8-8ab8-68d4705170d7

> FDA 483 for Onkos Surgical, Inc. on April 04, 2025. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Onkos Surgical, Inc.
- Inspection Date: 2025-04-04
- Product Type: device
- Office Name: New Jersey District Office
- Summary: Onkos Surgical, Inc. received a Form 483 citing significant deficiencies across its quality system, indicating a moderate level of severity. Observations include inadequate control over purchased products and services, failures in nonconformance investigations and CAPA execution, and ineffective risk management for its ELEOS implantable system. The firm also failed to report device corrections and removals that posed health risks to the FDA.

## Related Documents

- [483 - 2025-04-04](https://www.keypedia.com/records/483/onkos-surgical-inc/9db33922-6bd5-405f-86d0-c3ae806b01a4)
- [WARNING_LETTER - 2025-04-04](https://www.keypedia.com/records/warning_letter/onkos-surgical-inc/9260792b-edf0-4c89-89f3-90a9b4c15846)

## Related Officers

- [Jaro P. Perera](https://www.keypedia.com/people/jaro-p-perera/5555676c-2151-4ecd-bad8-72a1ddab8936)
- [Nakesh N. Gomanie](https://www.keypedia.com/people/nakesh-n-gomanie/cfffa8e1-fdfb-4bc4-a845-44bcd593c9c7)

Company: https://www.keypedia.com/companies/onkos-surgical-inc/dac92209-0126-41d3-a023-94ec8e29b4e4

Office: https://www.keypedia.com/offices/new-jersey-district-office/6ff5e2e9-5cff-44c7-af24-5a55329a8248