FDA Inspection
Structure Medical LLCStructure Medical LLC – FDA Inspection, Nov 21, 2014
Record Details
This FDA Inspection record concerns Structure Medical LLC, with an inspection on November 21, 2014, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- Structure Medical LLC
- Inspection Date
- November 21, 2014
- Product Type
- Devices
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ID · 80ee621f-dca5-4151-92f3-4982c363f605
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 905640
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
6- 21 CFR 820.75(a)Lack of or inadequate process validation
- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.22Quality audits - Lack of or inadequate procedures
- 21 CFR 820.198(a)Lack of or inadequate complaint procedures
- 21 CFR 820.50Purchasing controls, Lack of or inadequate procedures
- 21 CFR 820.70(a)Process control procedures, Lack of or inadequate procedures
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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 |
| March 3, 2017 | 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 1006383 - 2017-03-03
- FDA Inspection 889407 - 2014-08-01
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