FDA Inspection
Curonix LLCCuronix LLC – FDA Inspection, Feb 15, 2019
Record Details
This FDA Inspection record concerns Curonix LLC, with an inspection on February 15, 2019, issued by the Center for Devices and Radiological Health, covering devices.
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ID · d9f87d57-c2f2-47f2-a623-55ae4fdc0e0d
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1079720
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
- Outcome
- Form 483 issued
FDA Citations
4- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.30(i)Design changes - Lack of or Inadequate Procedures
- 21 CFR 820.198(a)Lack of or inadequate complaint procedures
- 21 CFR 820.90(b)(2)Product rework procedures, Lack of or inadequate procedures
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Other FDA inspections of Curonix LLC
3| Date | Classification | Office | Project area |
|---|---|---|---|
| November 8, 2023 | NAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
| June 24, 2022 | NAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
| January 29, 2016 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for Curonix LLC
- FDA Inspection 1223508 - 2023-11-08
- FDA Inspection 1174085 - 2022-06-24
- FDA Inspection 969946 - 2016-01-29
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