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FDA Inspection
•Direx Systems Corp.•April 12, 2017

Direx Systems Corp. – FDA Inspection, Apr 12, 2017

Record Details

This FDA Inspection record concerns Direx Systems Corp., with an inspection on April 12, 2017, issued by the Center for Devices and Radiological Health, covering devices.

Company
Direx Systems Corp.
Inspection Date
April 12, 2017
Product Type
Devices
Office
Center for Devices and Radiological Health
Person
  • John A. Sciacchitano (Company Rep)
View Company Profile

ID · eaac4170-8a4f-4ee0-a185-a0a926d14224

Inspection Facts

No Action Indicated (NAI)

No objectionable conditions or practices were found during the inspection.

Inspection number
1007613
FDA center
Medical Devices & Rad Health
Project area
Radiation Control and Health Safety Act
Outcome
Form 483 issued

FDA Citations

1
  1. 21 CFR 820.200(d)Service reports

Full citation text and observation details available on the Dashboard.

Other FDA inspections of Direx Systems Corp.

2
DateClassificationOfficeProject area
October 8, 2014VAICenter for Devices and Radiological HealthCompliance: Devices
April 4, 2012VAICenter for Devices and Radiological HealthCompliance: Devices
Other documents for Direx Systems Corp.
  • FDA Inspection 899351 - 2014-10-08
  • FDA Inspection 775404 - 2012-04-04

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