FDA Inspection
Contour Healer LLCContour Healer LLC – FDA Inspection, Nov 5, 2013
Record Details
This FDA Inspection record concerns Contour Healer LLC, with an inspection on November 5, 2013, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- Contour Healer LLC
- Inspection Date
- November 5, 2013
- Product Type
- Devices
View Company Profile
ID · 925256ad-50d2-414a-962b-89637ea746cc
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 857050
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
4- 21 CFR 820.20(a)Management ensuring quality policy is understood
- 21 CFR 820.20(c)Management review - defined interval, sufficient frequency
- 21 CFR 820.22Quality Audit/Reaudit - conducted
- 21 CFR 820.30(f)Design verification - documentation
Full citation text and observation details available on the Dashboard.
Other FDA inspections of Contour Healer LLC
2| Date | Classification | Office | Project area |
|---|---|---|---|
| September 15, 2023 | NAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
| July 20, 2017 | NAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
Other documents for Contour Healer LLC
- FDA Inspection 1218529 - 2023-09-15
- FDA Inspection 1024637 - 2017-07-20
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