FDA Inspection
Omnimate Enterprise Co., Ltd.Omnimate Enterprise Co., Ltd. – FDA Inspection, May 8, 2025
Record Details
This FDA Inspection record concerns Omnimate Enterprise Co., Ltd., with an inspection on May 8, 2025, issued by the Office of Inspections and Investigations, covering medical devices & rad health.
- Inspection Date
- May 8, 2025
- Product Type
- Medical Devices & Rad Health
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ID · 5f6c027f-27e3-481d-ae4e-f4bc254195ad
Inspection Facts
- Inspection number
- 1271152
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Medical Devices
- Outcome
- Form 483 issued
FDA Citations
3- 21 CFR 820.250(b)Sampling plans
- 21 CFR 820.70(c)Environmental control Lack of or inadequate procedures
- 21 CFR 820.75(a)Lack of or inadequate process validation
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Other FDA inspections of Omnimate Enterprise Co., Ltd.
1| Date | Classification | Office | Project area |
|---|---|---|---|
| September 12, 2019 | VAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
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