FDA Inspection
Infus Medical Co., Ltd.Infus Medical Co., Ltd. – FDA Inspection, Jun 12, 2025
Record Details
This FDA Inspection record concerns Infus Medical 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 · 964a4152-399a-42f4-b8e6-86b9999cd000
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1274830
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Medical Devices
- Outcome
- Form 483 issued
FDA Citations
2- 21 CFR 820.75(a)Lack of or inadequate process validation
- 21 CFR 820.198(c)Investigation of device failures
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Other FDA inspections of Infus Medical Co., Ltd.
1| Date | Classification | Office | Project area |
|---|---|---|---|
| January 26, 2017 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for Infus Medical Co., Ltd.
- FDA Inspection 1004672 - 2017-01-26
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