FDA Inspection
Renalytix AI, Inc.FDA Inspection 1268237 - Renalytix AI, Inc. - April 11, 2025
Record Details
This FDA Inspection record concerns Renalytix AI, Inc., with an inspection on April 11, 2025, issued by the Center for Devices and Radiological Health, covering devices.
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ID · 7593b93a-54f3-471d-9064-3125d79ee7df
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1268237
- FDA center
- Medical Devices & Rad Health
- Project area
- Postmarket Assurance: Devices
FDA Citations
2- 21 CFR 820.198(a)Lack of or inadequate complaint procedures
- 21 CFR 803.17Lack of Written MDR Procedures
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Other FDA inspections of Renalytix AI, Inc.
1| Date | Classification | Office | Project area |
|---|---|---|---|
| March 1, 2022 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for Renalytix AI, Inc.
- FDA Inspection 1165285 - 2022-03-01
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