D-REV: DESIGN FOR THE OTHER NINETY PERCENT – FDA Inspection, Oct 21, 2016

Record Details

This FDA Inspection record concerns D-REV: DESIGN FOR THE OTHER NINETY PERCENT, with an inspection on October 21, 2016, issued by the Center for Devices and Radiological Health, covering devices.

Company: D-REV: DESIGN FOR THE OTHER NINETY PERCENT
Inspection Date: October 21, 2016
Product Type: Devices
Office: Center for Devices and Radiological Health
Person: Quynh Strandberg (FDA Associated Person)

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ID · fe5975e5-59c5-4342-8d47-b3e480b675e3

Inspection Facts

Voluntary Action Indicated (VAI)

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

Inspection number: 999100
FDA center: Medical Devices & Rad Health
Project area: Compliance: Devices
Outcome: Form 483 issued

FDA Citations

21 CFR 820.198(a)Lack of or inadequate complaint procedures

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FDA Inspection

D-REV: DESIGN FOR THE OTHER NINETY PERCENTOctober 21, 2016