# FDA Inspection 1268237 - Renalytix AI, Inc. - April 11, 2025

Source: https://www.keypedia.com/records/fda_inspections/renalytix-ai-inc/7593b93a-54f3-471d-9064-3125d79ee7df
Source feed: FDA_Inspections

> FDA inspection 1268237 of Renalytix AI, Inc., April 11, 2025. Classification: Voluntary Action Indicated (VAI). 2 citations under 21 CFR parts 803 and 820. Form 483 issued. 1 other FDA inspection on record for this company.

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## Details

- Record Type: FDA Inspection
- Inspection ID: 1268237
- Company Name: Renalytix AI, Inc.
- Inspection Date: 2025-04-11
- Classification: Voluntary Action Indicated (VAI)
- Classification Code: VAI
- Project Area: Postmarket Assurance: Devices
- Product Type: Devices
- Center: Medical Devices & Rad Health
- Office Name: Center for Devices and Radiological Health
- Citation Count: 2

## Related Documents

- FDA Inspection 1165285 - 2022-03-01

## Related Officers

- [Investigator](https://www.keypedia.com/people/preston-m-lee/e44adac3-a915-4bfb-8b06-a41ea5803358)

Company: https://www.keypedia.com/companies/renalytix-ai-inc/01f12260-1201-4ce3-9c45-dd8ea2280b8a

Office: https://www.keypedia.com/offices/center-for-devices-and-radiological-health/9d89aff6-e435-4764-87be-f58c01aca7f7