FDA Inspection
Structure Medical LLCStructure Medical LLC – FDA Inspection, Mar 3, 2017
Record Details
This FDA Inspection record concerns Structure Medical LLC, with an inspection on March 3, 2017, issued by the Center for Devices and Radiological Health, covering devices.
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ID · 4d262f66-f1d3-483b-8796-f2c5c3b55a31
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1006383
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
- Outcome
- Form 483 issued
FDA Citations
4- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.22Quality audits - Lack of or inadequate procedures
- 21 CFR 820.80(a)Lack of or inadequate procedures - Acceptance activities
- 21 CFR 820.90(b)(2)Product rework adverse effects {see also 820.184}
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Other FDA inspections of Structure Medical LLC
3| Date | Classification | Office | Project area |
|---|---|---|---|
| January 19, 2024 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
| November 21, 2014 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
| August 1, 2014 | VAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
Other documents for Structure Medical LLC
- FDA Inspection 1228547 - 2024-01-19
- FDA Inspection 905640 - 2014-11-21
- FDA Inspection 889407 - 2014-08-01
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