FDA Inspection
SMCSMC – FDA Inspection, May 30, 2019
Record Details
This FDA Inspection record concerns SMC, with an inspection on May 30, 2019, issued by the Office of Inspections and Investigations, covering medical devices & rad health.
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ID · 4fb3dc87-c321-469f-b6cd-318d7821c407
Inspection Facts
- Inspection number
- 1091659
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
- Outcome
- Form 483 issued
FDA Citations
3- 21 CFR 820.184Lack of or inadequate DHR procedures
- 21 CFR 820.72(a)Calibration, Inspection, etc. Procedures Lack of or Inadequ
- 21 CFR 820.75(a)Lack of or inadequate process validation
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Other FDA inspections of SMC
1| Date | Classification | Office | Project area |
|---|---|---|---|
| December 11, 2025 | VAI | Office of Inspections and Investigations | Compliance: Medical Devices |
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