FDA Inspection
WINBACK GO EAST CO LTDWINBACK GO EAST CO LTD – FDA Inspection, Jun 12, 2025
Record Details
This FDA Inspection record concerns WINBACK GO EAST CO LTD, with an inspection on June 12, 2025, issued by the Office of Inspections and Investigations, covering medical devices & rad health.
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ID · 4cd30c80-fc24-40a6-a218-2a2a5f7aac64
Inspection Facts
No Action Indicated (NAI)
No objectionable conditions or practices were found during the inspection.
- Inspection number
- 1272426
- FDA center
- Medical Devices & Rad Health
- Project area
- Postmarket Assurance: Medical Devices
- Outcome
- Form 483 issued
FDA Citations
2- 21 CFR 820.198(a)Lack of or inadequate complaint procedures
- 21 CFR 830.300(a)Devices subject to device identification GUDID data submission requirements.
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