FDA Inspection
DermaMed Solutions, LLCDermaMed Solutions, LLC – FDA Inspection, May 5, 2014
Record Details
This FDA Inspection record concerns DermaMed Solutions, LLC, with an inspection on May 5, 2014, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- DermaMed Solutions, LLC
- Inspection Date
- May 5, 2014
- Product Type
- Devices
View Company Profile
ID · e162c2d6-b55b-4f8c-97ab-4808e651d459
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 871514
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
5- 21 CFR 820.198(c)Investigation of device failures
- 21 CFR 820.20(c)Management review - defined interval, sufficient frequency
- 21 CFR 820.80(a)Lack of or inadequate procedures - Acceptance activities
- 21 CFR 820.198(a)Lack of or inadequate complaint procedures
- 21 CFR 820.22Quality Audit/Reaudit - conducted
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Other FDA inspections of DermaMed Solutions, LLC
1| Date | Classification | Office | Project area |
|---|---|---|---|
| August 2, 2018 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
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