FDA Inspection
Encompass Group, LLCEncompass Group, LLC – FDA Inspection, Oct 12, 2017
Record Details
This FDA Inspection record concerns Encompass Group, LLC, with an inspection on October 12, 2017, issued by the Center for Devices and Radiological Health, covering devices.
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ID · 8344e236-be6c-44e4-9e99-8bbe346a1ef3
Inspection Facts
No Action Indicated (NAI)
No objectionable conditions or practices were found during the inspection.
- Inspection number
- 1028574
- FDA center
- Medical Devices & Rad Health
- Project area
- Postmarket Assurance: Devices
- Outcome
- Form 483 issued
FDA Citations
11- 21 CFR 820.100(b)Documentation
- 21 CFR 820.22Quality audits - Lack of or inadequate procedures
- 21 CFR 820.250(a)Statistical techniques - Lack of or inadequate procedures
- 21 CFR 820.50(a)(1)Documented evaluation
- 21 CFR 820.70(a)Process control procedures, Lack of or inadequate procedures
- 21 CFR 820.70(d)Training temp work under special environmental conditions
- 21 CFR 820.70(g)(1)Maintenance schedule, Lack of or inadequate schedule
- 21 CFR 820.70(i)Software validation for automated processes
- 21 CFR 820.72(a)Calibration, Inspection, etc. Procedures Lack of or Inadequ
- 21 CFR 820.75(a)Documentation
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