NovaSignal Corp. – FDA Inspection, Nov 1, 2017

Record Details

This FDA Inspection record concerns NovaSignal Corp., with an inspection on November 1, 2017, issued by the Center for Devices and Radiological Health, covering devices.

Company: NovaSignal Corp.
Inspection Date: November 1, 2017
Product Type: Devices
Office: Center for Devices and Radiological Health
Person: Janet Pulver (FDA Associated Person)

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ID · e98bf52a-1292-4721-be5c-1347abb40051

Inspection Facts

Voluntary Action Indicated (VAI)

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

Inspection number: 1030455
FDA center: Medical Devices & Rad Health
Project area: Compliance: Devices
Outcome: Form 483 issued

FDA Citations

21 CFR 820.30(c)Design input - Lack of or inadequate procedures
21 CFR 820.30(g)Design Validation - Risk analysis not performed/inadequate

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FDA Inspection

NovaSignal Corp.November 1, 2017