FDA Inspection
LSI Medience CorporationLSI Medience Corporation – FDA Inspection, Jun 13, 2017
Record Details
This FDA Inspection record concerns LSI Medience Corporation, with an inspection on June 13, 2017, issued by the Center for Devices and Radiological Health, covering devices.
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ID · 93ee9f3a-69ed-47c5-8590-cbd99cf984ca
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1014596
- FDA center
- Medical Devices & Rad Health
- Project area
- Postmarket Assurance: Devices
- Outcome
- Form 483 issued
FDA Citations
3- 21 CFR 820.50(a)(1)Evaluation and Selection, Suppliers, Contractors, etc.
- 21 CFR 820.70(i)Software validation for automated processes
- 21 CFR 803.17(a)(1)Lack of System for Event Evaluations
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