FDA Inspection
Arthrocare CorporationArthrocare Corporation – FDA Inspection, Mar 1, 2013
Record Details
This FDA Inspection record concerns Arthrocare Corporation, with an inspection on March 1, 2013, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- Arthrocare Corporation
- Inspection Date
- March 1, 2013
- Product Type
- Devices
View Company Profile
ID · 3a74a859-ceb4-4f9a-aabe-fe1b1122f621
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 821770
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
4- 21 CFR 820.100(b)Documentation
- 21 CFR 820.30(g)Design validation - user needs and intended uses
- 21 CFR 820.20(c)Management review - defined interval, sufficient frequency
- 21 CFR 820.100(a)Lack of or inadequate procedures
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Other FDA inspections of Arthrocare Corporation
2| Date | Classification | Office | Project area |
|---|---|---|---|
| November 17, 2023 | Not classified | Dallas District Office | |
| April 21, 2011 | NAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
Other documents for Arthrocare Corporation
- FDA Inspection 1224977 - 2023-11-17
- FDA Inspection 723758 - 2011-04-21
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