Provent Sleep Therapy LLC – FDA Inspection, Jan 3, 2018

Record Details

This FDA Inspection record concerns Provent Sleep Therapy LLC, with an inspection on January 3, 2018, issued by the Center for Devices and Radiological Health, covering devices.

Company: Provent Sleep Therapy LLC
Inspection Date: January 3, 2018
Product Type: Devices
Office: Center for Devices and Radiological Health
Person: Stephen C. Smith (FDA Associated Person)

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ID · e1ff8992-c949-45f4-91f1-9dd4af88156e

Inspection Facts

Voluntary Action Indicated (VAI)

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

Inspection number: 1037656
FDA center: Medical Devices & Rad Health
Project area: Compliance: Devices
Outcome: Form 483 issued

FDA Citations

21 CFR 803.50(a)(2)Individual Report of Malfunction

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FDA Inspection

Provent Sleep Therapy LLCJanuary 3, 2018