# O.N. Diagnostics, LLC – FDA 483, Mar 17, 2026

Source: https://www.keypedia.com/records/483/on-diagnostics-llc/319a4764-55eb-448c-a792-7f8f7deac301

> FDA 483 for O.N. Diagnostics, LLC on March 17, 2026. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: O.N. Diagnostics, LLC
- Inspection Date: 2026-03-17
- Product Type: device
- Office Name: San Francisco District Office
- Summary: O.N. Diagnostics, LLC in Berkeley, CA, a manufacturer, was cited for significant deficiencies in its corrective and preventive action (CAPA) procedures. The inspection revealed a failure to adequately document and verify the effectiveness of corrective actions, leading to recurring nonconformities and a systemic lack of risk-based control over their CAPA process. Additionally, the firm did not evaluate the risk of significant changes to its critical quality system processes before implementation.

## Related Officers

- [Nga T. Ho](https://www.keypedia.com/people/nga-t-ho/7c7d96a2-9b2c-4966-8dc2-ee20ca024be1)
- [Sasha L. Eckstein](https://www.keypedia.com/people/sasha-l-eckstein/97a787c8-76da-481f-b18c-8f9d5f0131e1)

Company: https://www.keypedia.com/companies/on-diagnostics-llc/15cd72c6-87bd-4541-b232-dd34f718779a

Office: https://www.keypedia.com/offices/san-francisco-district-office/6f838e9c-aae1-4665-9c46-a51d43be02df