FDA Inspection
dMedicus, LLCdMedicus, LLC – FDA Inspection, Mar 11, 2011
Record Details
This FDA Inspection record concerns dMedicus, LLC, with an inspection on March 11, 2011, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- dMedicus, LLC
- Inspection Date
- March 11, 2011
- Product Type
- Devices
View Company Profile
ID · a7293402-14f8-484c-b929-de3a10175b77
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 715136
- FDA center
- Medical Devices & Rad Health
- Project area
- Postmarket Assurance: Devices
FDA Citations
5- 21 CFR 820.20(c)Management review - defined interval, sufficient frequency
- 21 CFR 820.198(a)Lack of or inadequate complaint procedures
- 21 CFR 820.22Quality Audit/Reaudit - conducted
- 21 CFR 820.200(d)Service reports
- 21 CFR 803.17Lack of Written MDR Procedures
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