FDA Inspection
SINO MEDICAL SCIENCES TECHNOLOGY INC.SINO MEDICAL SCIENCES TECHNOLOGY INC. – FDA Inspection, Aug 24, 2023
Record Details
This FDA Inspection record concerns SINO MEDICAL SCIENCES TECHNOLOGY INC., with an inspection on August 24, 2023, issued by the Center for Devices and Radiological Health, covering devices.
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ID · b3a2bd91-81b5-444e-8dad-57a10957eabb
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 1217707
- FDA center
- Medical Devices & Rad Health
- Project area
- Postmarket Assurance: Devices
- Outcome
- Form 483 issued
FDA Citations
3- 21 CFR 803.17Lack of Written MDR Procedures
- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.30(g)Design validation- Lack of or inadequate procedures
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Other FDA inspections of SINO MEDICAL SCIENCES TECHNOLOGY INC.
1| Date | Classification | Office | Project area |
|---|---|---|---|
| March 31, 2025 | Not classified | Office of Inspections and Investigations |
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