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FDA Inspection
•DongBang Medical Co. Ltd.•April 6, 2017

DongBang Medical Co. Ltd. – FDA Inspection, Apr 6, 2017

Record Details

This FDA Inspection record concerns DongBang Medical Co. Ltd., with an inspection on April 6, 2017, issued by the Office of Inspections and Investigations, covering medical devices & rad health.

Company
DongBang Medical Co. Ltd.
Inspection Date
April 6, 2017
Product Type
Medical Devices & Rad Health
Office
Office of Inspections and Investigations
Person
  • Amy M. Cramer (Issuing Officer)
View Company Profile

ID · 9021e8c2-e87c-4b0e-891f-887863147e97

Inspection Facts

Inspection number
1016322
FDA center
Medical Devices & Rad Health
Project area
Compliance: Devices
Outcome
Form 483 issued

FDA Citations

1
  1. 21 CFR 820.30(f)Design verification - output does not meet input requirement

Full citation text and observation details available on the Dashboard.

Other FDA inspections of DongBang Medical Co. Ltd.

1
DateClassificationOfficeProject area
June 19, 2025Not classifiedOffice of Inspections and Investigations
Other documents for DongBang Medical Co. Ltd.
  • FDA Inspection 1286936 - 2025-06-19

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