Paragon Music, Inc. – FDA Inspection, Jul 20, 2018

Record Details

This FDA Inspection record concerns Paragon Music, Inc., with an inspection on July 20, 2018, issued by the Center for Devices and Radiological Health, covering devices.

Company: Paragon Music, Inc.
Inspection Date: July 20, 2018
Product Type: Devices
Office: Center for Devices and Radiological Health
Person: Joshua J. Silvestri

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ID · 6dceaa11-678b-4762-992b-57d805a11f56

Inspection Facts

Voluntary Action Indicated (VAI)

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

Inspection number: 1060881
FDA center: Medical Devices & Rad Health
Project area: Radiation Control and Health Safety Act
Outcome: Form 483 issued

FDA Citations

21 CFR 1040.11(c)Demonstration laser products
21 CFR 1002.40(a)Obtaining info on first purchasers

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FDA Inspection

Paragon Music, Inc.July 20, 2018