FDA Inspection
Solco Biomedical Co., Ltd.Solco Biomedical Co., Ltd. – FDA Inspection, Nov 24, 2016
Record Details
This FDA Inspection record concerns Solco Biomedical Co., Ltd., with an inspection on November 24, 2016, issued by the Office of Inspections and Investigations, covering medical devices & rad health.
- Company
- Solco Biomedical Co., Ltd.
- Inspection Date
- November 24, 2016
- Product Type
- Medical Devices & Rad Health
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ID · 22b0b9e3-541e-40a1-bd0f-86097ee65dd5
Inspection Facts
- Inspection number
- 994660
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
- Outcome
- Form 483 issued
FDA Citations
3- 21 CFR 803.50(a)(1)Report of Death or Serious Injury
- 21 CFR 820.250(b)Sampling plans
- 21 CFR 820.30(g)Design Validation - Risk analysis not performed/inadequate
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Other FDA inspections of Solco Biomedical Co., Ltd.
2| Date | Classification | Office | Project area |
|---|---|---|---|
| December 19, 2024 | VAI | Office of Inspections and Investigations | Compliance: Medical Devices |
| September 12, 2013 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for Solco Biomedical Co., Ltd.
- FDA Inspection 1256802 - 2024-12-19
- FDA Inspection 853887 - 2013-09-12
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