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FDA Inspection
•Denterprise International, Inc.•March 12, 2018

Denterprise International, Inc. – FDA Inspection, Mar 12, 2018

Record Details

This FDA Inspection record concerns Denterprise International, Inc., with an inspection on March 12, 2018, issued by the Center for Devices and Radiological Health, covering devices.

Company
Denterprise International, Inc.
Inspection Date
March 12, 2018
Product Type
Devices
Office
Center for Devices and Radiological Health
Person
  • Joshua J. Silvestri
View Company Profile

ID · dc90acb6-d501-4a74-a545-4341e2046381

Inspection Facts

Official Action Indicated (OAI)

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

Inspection number
1044362
FDA center
Medical Devices & Rad Health
Project area
Postmarket Assurance: Devices
Outcome
Form 483 issued

Other FDA inspections of Denterprise International, Inc.

3
DateClassificationOfficeProject area
August 19, 2021VAICenter for Devices and Radiological HealthCompliance: Devices
May 6, 2019OAICenter for Devices and Radiological HealthCompliance: Devices
July 29, 2016VAICenter for Devices and Radiological HealthCompliance: Devices
Other documents for Denterprise International, Inc.
  • FDA Inspection 1149181 - 2021-08-19
  • FDA Inspection 1090180 - 2019-05-06
  • FDA Inspection 982613 - 2016-07-29

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