FDA Inspection
Curonix LLCCuronix LLC – FDA Inspection, Nov 8, 2023
Record Details
This FDA Inspection record concerns Curonix LLC, with an inspection on November 8, 2023, issued by the Center for Devices and Radiological Health, covering devices.
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ID · 77b57c36-3ef7-4189-9331-aca2df7b6e24
Inspection Facts
No Action Indicated (NAI)
No objectionable conditions or practices were found during the inspection.
- Inspection number
- 1223508
- FDA center
- Medical Devices & Rad Health
- Project area
- Postmarket Assurance: Devices
- Outcome
- Form 483 issued
FDA Citations
4- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.198(a)Lack of or inadequate complaint procedures
- 21 CFR 820.70(i)Software validation for automated processes
- 21 CFR 820.90(b)(1)Procedures for product review,disposition lack of/inadequate
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Other FDA inspections of Curonix LLC
3| Date | Classification | Office | Project area |
|---|---|---|---|
| June 24, 2022 | NAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
| February 15, 2019 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
| January 29, 2016 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for Curonix LLC
- FDA Inspection 1174085 - 2022-06-24
- FDA Inspection 1079720 - 2019-02-15
- FDA Inspection 969946 - 2016-01-29
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