FDA Inspection
Structure Medical LLCStructure Medical LLC – FDA Inspection, Aug 1, 2014
Record Details
This FDA Inspection record concerns Structure Medical LLC, with an inspection on August 1, 2014, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- Structure Medical LLC
- Inspection Date
- August 1, 2014
- Product Type
- Devices
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ID · dade0dff-51ed-483b-adfc-de2c82acbea7
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 889407
- FDA center
- Medical Devices & Rad Health
- Project area
- Postmarket Assurance: Devices
FDA Citations
7- 21 CFR 820.80(e)Documentation
- 21 CFR 820.25(b)Training records
- 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 820.184DHR content
- 21 CFR 803.17Lack of Written MDR Procedures
Full citation text and observation details available on the Dashboard.
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 |
| November 21, 2014 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for Structure Medical LLC
- FDA Inspection 1228547 - 2024-01-19
- FDA Inspection 1006383 - 2017-03-03
- FDA Inspection 905640 - 2014-11-21
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