FDA Inspection
Suture ConceptsSuture Concepts – FDA Inspection, Dec 8, 2016
Record Details
This FDA Inspection record concerns Suture Concepts, with an inspection on December 8, 2016, issued by the Center for Devices and Radiological Health, covering devices.
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ID · 6e4dc0df-cee7-4997-8c36-1bbe10329b73
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 993872
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
- Outcome
- Form 483 issued
FDA Citations
1- 21 CFR 820.60Identification procedures, Lack of or inadequate procedures
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Other FDA inspections of Suture Concepts
2| Date | Classification | Office | Project area |
|---|---|---|---|
| December 20, 2021 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
| January 14, 2013 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
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