de Gotzen S.r.l. – FDA Inspection, Dec 21, 2017

Record Details

This FDA Inspection record concerns de Gotzen S.r.l., with an inspection on December 21, 2017, issued by the Center for Devices and Radiological Health, covering devices.

Company: de Gotzen S.r.l.
Inspection Date: December 21, 2017
Product Type: Devices
Office: Center for Devices and Radiological Health
Person: Ashley A. Mutawakkil (Investigator)

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ID · 994697ee-7fbe-4ed4-b306-9199c0504550

Inspection Facts

Official Action Indicated (OAI)

Significant objectionable conditions were found and regulatory or administrative action is recommended.

Inspection number: 1037479
FDA center: Medical Devices & Rad Health
Project area: Compliance: Devices
Outcome: Form 483 issued

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FDA Inspection

de Gotzen S.r.l.December 21, 2017