SAN YANG ELECTRIC CO., LTD. – FDA Inspection, Mar 30, 2017

Record Details

This FDA Inspection record concerns SAN YANG ELECTRIC CO., LTD., with an inspection on March 30, 2017, issued by the Center for Devices and Radiological Health, covering devices.

Company: SAN YANG ELECTRIC CO., LTD.
Inspection Date: March 30, 2017
Product Type: Devices
Office: Center for Devices and Radiological Health
Person: Thai T. Duong (Issuing Officer)

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ID · fedd16fc-219c-474b-a1a4-3ac9718c03a6

Inspection Facts

Official Action Indicated (OAI)

Significant objectionable conditions were found and regulatory or administrative action is recommended.

Inspection number: 1008068
FDA center: Medical Devices & Rad Health
Project area: Compliance: Devices
Outcome: Form 483 issued

FDA Citations

21 CFR 820.30(a)Design control - no procedures
21 CFR 820.70(a)Production processes
21 CFR 803.17Lack of Written MDR Procedures

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FDA Inspection

SAN YANG ELECTRIC CO., LTD.March 30, 2017