Marriott, Inc. – FDA Inspection, Sep 25, 2018

Record Details

This FDA Inspection record concerns Marriott, Inc., with an inspection on September 25, 2018, issued by the Center for Devices and Radiological Health, covering devices.

Company: Marriott, Inc.
Inspection Date: September 25, 2018
Product Type: Devices
Office: Center for Devices and Radiological Health
Person: Joshua J. Silvestri

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ID · d254795b-c753-48d9-b182-97ded8c1566e

Inspection Facts

Official Action Indicated (OAI)

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

Inspection number: 1066863
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 1002.13Failure to submit

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FDA Inspection

Marriott, Inc.September 25, 2018