Orion Vision Group – FDA Inspection, Sep 20, 2018

Record Details

This FDA Inspection record concerns Orion Vision Group, with an inspection on September 20, 2018, issued by the Center for Devices and Radiological Health, covering devices.

Company: Orion Vision Group
Inspection Date: September 20, 2018
Product Type: Devices
Office: Center for Devices and Radiological Health
Person: Dawn M. Braswell (Investigator)

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ID · 943b36e2-2bde-4a00-9879-3224f1ba41c0

Inspection Facts

Voluntary Action Indicated (VAI)

Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.

Inspection number: 1066311
FDA center: Medical Devices & Rad Health
Project area: Compliance: Devices
Outcome: Form 483 issued

FDA Citations

21 CFR 820.40Procedures not adequately established or maintained
21 CFR 820.80(b)Lack of or inadequate receiving acceptance procedures
21 CFR 820.100(a)Lack of or inadequate procedures
21 CFR 820.198(a)Lack of or inadequate complaint procedures
21 CFR 820.25(b)Training - Lack of or inadequate procedures
21 CFR 820.70(c)Environmental control Lack of or inadequate procedures
21 CFR 820.72(a)Calibration, Inspection, etc. Procedures Lack of or Inadequ
21 CFR 820.50Purchasing controls, Lack of or inadequate procedures
21 CFR 820.198(b)Rationale documented for no investigation
21 CFR 820.30(j)Design history file

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Other FDA inspections of Orion Vision Group

Date	Classification	Office	Project area
March 15, 2024	VAI	Center for Devices and Radiological Health	Compliance: Devices
March 29, 2017	VAI	Center for Devices and Radiological Health	Compliance: Devices
March 8, 2013	VAI	Center for Devices and Radiological Health	Postmarket Assurance: Devices
February 9, 2011	OAI	Center for Devices and Radiological Health	Compliance: Devices