FDA Inspection
Structure Medical LLCStructure Medical LLC – FDA Inspection, May 5, 2023
Record Details
This FDA Inspection record concerns Structure Medical LLC, with an inspection on May 5, 2023, issued by the Center for Devices and Radiological Health, covering devices.
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ID · a8a3e137-4b56-4045-82c1-a76bcf55d721
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1204627
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
- Outcome
- Form 483 issued
FDA Citations
1- 21 CFR 820.75(a)Lack of or inadequate process validation
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Other FDA inspections of Structure Medical LLC
2| Date | Classification | Office | Project area |
|---|---|---|---|
| September 11, 2025 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
| July 11, 2017 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for Structure Medical LLC
- FDA Inspection 1283150 - 2025-09-11
- FDA Inspection 1028089 - 2017-07-11
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