FDA Inspection
GTG Wellness Co., Ltd.GTG Wellness Co., Ltd. – FDA Inspection, Mar 23, 2023
Record Details
This FDA Inspection record concerns GTG Wellness Co., Ltd., with an inspection on March 23, 2023, issued by the Center for Devices and Radiological Health, covering devices.
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ID · 9ce7ddd7-7d1c-4f6c-8738-2b11c963107b
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1202194
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
- Outcome
- Form 483 issued
FDA Citations
6- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.120Lack of or inadequate procedures for labeling
- 21 CFR 820.86Acceptance status
- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.120Lack of or inadequate procedures for labeling
- 21 CFR 820.86Acceptance status
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