ProHealth Inc. – FDA Inspection, Dec 18, 2025

Record Details

This FDA Inspection record concerns ProHealth Inc., with an inspection on December 18, 2025, issued by the Center for Devices and Radiological Health, covering devices.

Company: ProHealth Inc.
Inspection Date: December 18, 2025
Product Type: Devices
Office: Center for Devices and Radiological Health
Person: Laureen M. Geniusz (FDA Associated Person)

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ID · f826c7ba-8d18-4ba7-93c9-ab2566aec9e9

Inspection Facts

Voluntary Action Indicated (VAI)

Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.

Inspection number: 1295860
FDA center: Medical Devices & Rad Health
Project area: Compliance: Devices

FDA Citations

21 CFR 820.30(f)Design verification - output does not meet input requirement
21 CFR 830.300(a)Devices subject to device identification GUDID data submission requirements.

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FDA Inspection

ProHealth Inc.December 18, 2025