Synedgen Inc. – FDA Inspection, Jul 26, 2019

Record Details

This FDA Inspection record concerns Synedgen Inc., with an inspection on July 26, 2019, issued by the Center for Devices and Radiological Health, covering devices.

Company: Synedgen Inc.
Inspection Date: July 26, 2019
Product Type: Devices
Office: Center for Devices and Radiological Health
People: Angelica G Aziz (Issuing Officer)
Esteban Beltran (Issuing Officer)

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ID · d3da6f07-7c93-4062-b0e4-7111450d4c45

Inspection Facts

No Action Indicated (NAI)

No objectionable conditions or practices were found during the inspection.

Inspection number: 1097763
FDA center: Medical Devices & Rad Health
Project area: Postmarket Assurance: Devices
Outcome: Form 483 issued

FDA Citations

21 CFR 820.20(c)Management review - Lack of or inadequate procedures
21 CFR 820.22Quality Audit/Reaudit - conducted

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FDA Inspection

Synedgen Inc.July 26, 2019