FDA Inspection
SMCSMC – FDA Inspection, Dec 11, 2025
Record Details
This FDA Inspection record concerns SMC, with an inspection on December 11, 2025, issued by the Office of Inspections and Investigations, covering medical devices & rad health.
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ID · b325cce0-75e5-43fb-8525-7e652ee6c7dd
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1296686
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Medical 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 820.50(b)Supplier notification of changes
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Other FDA inspections of SMC
1| Date | Classification | Office | Project area |
|---|---|---|---|
| May 30, 2019 | Not classified | Office of Inspections and Investigations | Compliance: Devices |
Other documents for SMC
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