FDA Inspection
SM ENG. Co. Ltd.SM ENG. Co. Ltd. – FDA Inspection, Mar 26, 2026
Record Details
This FDA Inspection record concerns SM ENG. Co. Ltd., with an inspection on March 26, 2026, issued by the Office of Inspections and Investigations, covering medical devices & rad health.
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ID · 63d4454a-f206-45c0-85ac-7c8cf8a602a2
Inspection Facts
- Inspection number
- 1311000
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
- Outcome
- Form 483 issued
FDA Citations
2- ISO 13485:2016 Clause 7.5.6Procedures for validation of processes not documented
- ISO 13485:2016 Clause 7.5.7Processes for sterilization and sterile barrier systems not validated
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Other FDA inspections of SM ENG. Co. Ltd.
2| Date | Classification | Office | Project area |
|---|---|---|---|
| July 21, 2023 | VAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
| July 25, 2019 | Not classified | Office of Inspections and Investigations |
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