FDA Inspection

ORAL IQ LLCFebruary 23, 2024

FDA Inspection 1231104 - ORAL IQ LLC - February 23, 2024

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Record Details

This FDA Inspection record concerns ORAL IQ LLC, with an inspection on February 23, 2024, issued by the Center for Devices and Radiological Health, covering devices.

Company: ORAL IQ LLC
Inspection Date: February 23, 2024
Product Type: Devices
Office: Center for Devices and Radiological Health
Person: Sarah A. Hassas (Company Rep)

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ID · d83fbd3e-a752-473d-a40d-bbc863616c43

Inspection Facts

Voluntary Action Indicated (VAI)

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

Inspection number: 1231104
FDA center: Medical Devices & Rad Health
Project area: Compliance: Devices

FDA Citations

21 CFR 820.30(h)Design transfer - Lack of or inadequate procedures
21 CFR 820.30(e)Design review - documentation

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