Careox, LlcAugust 29, 2025

FDA 483 - Careox, Llc - August 29, 2025

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Record Details

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.

Company: Careox, Llc
Inspection Date: August 29, 2025
Product Type: Other
Office: New Jersey District Office
Person: Frank J. Marciniak

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ID · e89ed067-9d79-475e-a1c8-60a14ecb1c03