FDA Inspection
CoreLink LLCCoreLink LLC – FDA Inspection, Feb 4, 2013
Record Details
This FDA Inspection record concerns CoreLink LLC, with an inspection on February 4, 2013, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- CoreLink LLC
- Inspection Date
- February 4, 2013
- Product Type
- Devices
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ID · 0ff121d5-a567-4c96-bc06-f5f1ee362050
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 818928
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
3- 21 CFR 820.100(b)Documentation
- 21 CFR 820.30(e)Design review - Lack of or inadequate procedures
- 21 CFR 820.22Quality Audits - defined intervals
Full citation text and observation details available on the Dashboard.
Other FDA inspections of CoreLink LLC
4| Date | Classification | Office | Project area |
|---|---|---|---|
| July 27, 2022 | NAI | Center for Biologics Evaluation and Research | Human Cellular, Tissue, and Gene Therapies |
| July 21, 2017 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
| July 9, 2015 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
| November 12, 2010 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for CoreLink LLC
- FDA Inspection 1176784 - 2022-07-27
- FDA Inspection 1019655 - 2017-07-21
- FDA Inspection 933648 - 2015-07-09
- FDA Inspection 698189 - 2010-11-12
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