# FDA 483 - Richmond Diagnostics, Inc. - July 25, 2025

Source: https://www.keypedia.com/records/483/richmond-diagnostics-inc/98727569-067e-4125-ad78-afeff7e38ad2

> FDA 483 for Richmond Diagnostics, Inc. on July 25, 2025. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Richmond Diagnostics, Inc.
- Inspection Date: 2025-07-25
- Product Type: device
- Office Name: New Jersey District Office
- Summary: An FDA inspection of Richmond Diagnostics, Inc. in North Brunswick, NJ, revealed significant deficiencies in their quality system. Observations included failures to ensure device history records demonstrate manufacturing in accordance with master records, inadequate procedures for corrective and preventive actions, and a lack of established procedures to control nonconforming product.

## Related Officers

- [Frank J. Marciniak](https://www.keypedia.com/people/frank-j-marciniak/6995351a-6afc-4056-9692-d4aeb711dd92)

Company: https://www.keypedia.com/companies/richmond-diagnostics-inc/379ec83e-6c23-4adb-bbdc-8f52b5b7e1a0

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