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FDA Inspection
•Bionet Co., Ltd.•February 21, 2019

Bionet Co., Ltd. – FDA Inspection, Feb 21, 2019

Record Details

This FDA Inspection record concerns Bionet Co., Ltd., with an inspection on February 21, 2019, issued by the Center for Devices and Radiological Health, covering devices.

Company
Bionet Co., Ltd.
Inspection Date
February 21, 2019
Product Type
Devices
Office
Center for Devices and Radiological Health
Person
  • Christina L. Bigham (FDA Associated Person)
View Company Profile

ID · fe666d17-7320-4bde-88a0-31d947b38ec7

Inspection Facts

Voluntary Action Indicated (VAI)

Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.

Inspection number
1082597
FDA center
Medical Devices & Rad Health
Project area
Compliance: Devices
Outcome
Form 483 issued

Other FDA inspections of Bionet Co., Ltd.

2
DateClassificationOfficeProject area
January 17, 2013VAICenter for Devices and Radiological HealthCompliance: Devices
April 21, 2011OAICenter for Devices and Radiological HealthCompliance: Devices
Other documents for Bionet Co., Ltd.
  • FDA Inspection 816934 - 2013-01-17
  • FDA Inspection 727569 - 2011-04-21

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