FDA Inspection
Outcome Solutions, LLCOutcome Solutions, LLC – FDA Inspection, Mar 6, 2015
Record Details
This FDA Inspection record concerns Outcome Solutions, LLC, with an inspection on March 6, 2015, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- Outcome Solutions, LLC
- Inspection Date
- March 6, 2015
- Product Type
- Devices
View Company Profile
ID · cd212ac4-6d82-40ea-8a35-8d7aa46f0da0
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 917554
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
8- 21 CFR 820.181DMR - not or inadequately maintained
- 21 CFR 820.198(c)Investigation of device failures
- 21 CFR 820.20(c)Management review - defined interval, sufficient frequency
- 21 CFR 820.30(i)Design changes - Lack of or Inadequate Procedures
- 21 CFR 820.80(d)Lack of or inadequate final acceptance procedures
- 21 CFR 820.25(b)Training - Lack of or inadequate procedures
- 21 CFR 820.50(b)Approval, inadequate purchasing data
- 21 CFR 820.22Quality Audit/Reaudit - conducted
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