STG24 CO.,LTD. – FDA Inspection, Dec 14, 2023

Record Details

This FDA Inspection record concerns STG24 CO.,LTD., with an inspection on December 14, 2023, issued by the Center for Devices and Radiological Health, covering devices.

Company: STG24 CO.,LTD.
Inspection Date: December 14, 2023
Product Type: Devices
Office: Center for Devices and Radiological Health
Person: Marlo-Ian M. Alintanahin (Issuing Officer)

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ID · b54d82e4-d228-49a0-a361-85e1e6548888

Inspection Facts

Official Action Indicated (OAI)

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

Inspection number: 1226484
FDA center: Medical Devices & Rad Health
Project area: Compliance: Devices
Outcome: Form 483 issued

FDA Citations

21 CFR 820.30(b)Design plans- updated
21 CFR 803.17Lack of Written MDR Procedures
21 CFR 803.17Lack of Written MDR Procedures
21 CFR 820.30(b)Design plans- updated

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FDA Inspection

STG24 CO.,LTD.December 14, 2023