SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO., LTD. – FDA Inspection, Apr 14, 2017

Record Details

This FDA Inspection record concerns SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO., LTD., with an inspection on April 14, 2017, issued by the Center for Devices and Radiological Health, covering devices.

Company: SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO., LTD.
Inspection Date: April 14, 2017
Product Type: Devices
Office: Center for Devices and Radiological Health
Person: Stephen D. Eich (Company Rep)

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ID · cdd72fa3-5be0-4de9-b0db-9408c563deb3

Inspection Facts

Voluntary Action Indicated (VAI)

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

Inspection number: 1010956
FDA center: Medical Devices & Rad Health
Project area: Compliance: Devices
Outcome: Form 483 issued

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FDA Inspection

SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO., LTD.April 14, 2017