FDA Inspection
SM ENG. Co. Ltd.SM ENG. Co. Ltd. – FDA Inspection, Jul 21, 2023
Record Details
This FDA Inspection record concerns SM ENG. Co. Ltd., with an inspection on July 21, 2023, issued by the Center for Devices and Radiological Health, covering devices.
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ID · 8617b7dc-e844-415a-9dcf-8de6a3c962f5
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1214471
- FDA center
- Medical Devices & Rad Health
- Project area
- Postmarket Assurance: Devices
- Outcome
- Form 483 issued
FDA Citations
4- 21 CFR 820.75(a)Lack of or inadequate process validation
- 21 CFR 820.75(b)Lack/Inad procedure-Monitoring/Control of Validated Proces
- 21 CFR 820.75(a)Lack of or inadequate process validation
- 21 CFR 820.75(b)Lack/Inad procedure-Monitoring/Control of Validated Proces
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Other FDA inspections of SM ENG. Co. Ltd.
2| Date | Classification | Office | Project area |
|---|---|---|---|
| March 26, 2026 | Not classified | Office of Inspections and Investigations | Compliance: Devices |
| July 25, 2019 | Not classified | Office of Inspections and Investigations |
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