# FDA 483 - Careox, Llc - August 29, 2025

Source: https://www.keypedia.com/records/483/careox-llc/e89ed067-9d79-475e-a1c8-60a14ecb1c03

> FDA 483 for Careox, Llc on August 29, 2025. Product: other. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Careox, Llc
- Inspection Date: 2025-08-29
- Product Type: other
- Office Name: New Jersey District Office
- Summary: An FDA inspection of Careox, Llc in Princeton, NJ, a medical device manufacturer, revealed two significant observations. The firm was cited for failing to establish written procedures for medical device reporting (MDR) and for not having established procedures for receiving, reviewing, and evaluating complaints.

## Related Documents

- [483 - 2025-08-29](https://www.keypedia.com/records/483/careox-llc/976c6103-5fca-4f79-ad49-32eb935f81b4)

## Related Officers

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

Company: https://www.keypedia.com/companies/careox-llc/d12461e8-889a-4a6f-87ee-d0f3b88a30f1

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