FDA Inspection
Light Portal Technologies, LLCLight Portal Technologies, LLC – FDA Inspection, Jan 28, 2014
Record Details
This FDA Inspection record concerns Light Portal Technologies, LLC, with an inspection on January 28, 2014, issued by the Center for Devices and Radiological Health, covering devices.
- Inspection Date
- January 28, 2014
- Product Type
- Devices
View Company Profile
ID · 3a4d9069-0ac6-49b6-810c-79621b6ccc9c
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 863583
- FDA center
- Medical Devices & Rad Health
- Project area
- Postmarket Assurance: Devices
FDA Citations
7- 21 CFR 820.80(a)Lack of or inadequate procedures - Acceptance activities
- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.30(a)Design control - no procedures
- 21 CFR 820.198(a)Lack of or inadequate complaint procedures
- 21 CFR 820.70(a)Production processes
- 21 CFR 820.30(j)Design history file
- 21 CFR 803.17Lack of Written MDR Procedures
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