Amata Medicare Co., Ltd. – FDA Inspection, Aug 31, 2023

Record Details

This FDA Inspection record concerns Amata Medicare Co., Ltd., with an inspection on August 31, 2023, issued by the Office of Inspections and Investigations.

Company: Amata Medicare Co., Ltd.
Inspection Date: August 31, 2023
Office: Office of Inspections and Investigations
Person: David J. Gasparovich (Issuing Officer)

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ID · 5cd8bfda-dc9c-4988-9504-cf2feb9cf097

Inspection Facts

Inspection number: 1216995
FDA center: Medical Devices & Rad Health
Outcome: Form 483 issued

FDA Citations

21 CFR 820.100(a)Lack of or inadequate procedures

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FDA Inspection

Amata Medicare Co., Ltd.August 31, 2023