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FDA Inspection
•GE Healthcare - Repair Operations Center•July 18, 2023

GE Healthcare - Repair Operations Center – FDA Inspection, Jul 18, 2023

Record Details

This FDA Inspection record concerns GE Healthcare - Repair Operations Center, with an inspection on July 18, 2023, issued by the Center for Devices and Radiological Health, covering devices.

Company
GE Healthcare - Repair Operations Center
Inspection Date
July 18, 2023
Product Type
Devices
Office
Center for Devices and Radiological Health
Person
  • Jesse A. Vazquez (FDA Associated Person)
View Company Profile

ID · d2545232-8f1f-45a2-bc84-2e4e5a092145

Inspection Facts

No Action Indicated (NAI)

No objectionable conditions or practices were found during the inspection.

Inspection number
1210335
FDA center
Medical Devices & Rad Health
Project area
Postmarket Assurance: Devices
Outcome
Form 483 issued

FDA Citations

1
  1. 21 CFR 820.100(a)Lack of or inadequate procedures

Full citation text and observation details available on the Dashboard.

Other FDA inspections of GE Healthcare - Repair Operations Center

1
DateClassificationOfficeProject area
February 1, 2019NAICenter for Devices and Radiological HealthCompliance: Devices
Other documents for GE Healthcare - Repair Operations Center
  • FDA Inspection 1083962 - 2019-02-01

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