Orion Vision Group – FDA Inspection, Mar 15, 2024

Record Details

This FDA Inspection record concerns Orion Vision Group, with an inspection on March 15, 2024, issued by the Center for Devices and Radiological Health, covering devices.

Company: Orion Vision Group
Inspection Date: March 15, 2024
Product Type: Devices
Office: Center for Devices and Radiological Health
Person: Jamie P. Webb (Issuing Officer)

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ID · 9e0cccae-2220-4f42-8619-f4477d7f01d1

Inspection Facts

Voluntary Action Indicated (VAI)

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

Inspection number: 1229527
FDA center: Medical Devices & Rad Health
Project area: Compliance: Devices

FDA Citations

21 CFR 820.80(b)Lack of or inadequate receiving acceptance procedures
21 CFR 820.90(a)Nonconforming product, Lack of or inadequate procedures
21 CFR 820.30(j)Design history file
21 CFR 820.70(c)Environmental control Lack of or inadequate procedures
21 CFR 820.50Purchasing controls, Lack of or inadequate procedures
21 CFR 820.70(a)Process control procedures, Lack of or inadequate procedures
21 CFR 820.22Quality audits - Lack of or inadequate procedures
21 CFR 820.198(a)Lack of or inadequate complaint procedures
21 CFR 820.100(a)Lack of or inadequate procedures
21 CFR 820.198(e)Records of complaint investigation

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Other FDA inspections of Orion Vision Group

Date	Classification	Office	Project area
September 20, 2018	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