Orion Vision
1800 Sandy Plains Ind Prkwy, Marietta, GA, US
Registered product codes
1 product codes
Recent MDR events
0 on file
No MDR events on file for this firm name.
Recalls
0 on file
No recalls on file for this firm name.
Compliance history
Matched by FEI 1000140384.
FDA inspections
2 on file
- Voluntary Action Indicated (VAI)Mar 15, 2024
Compliance: Devices · Citations posted
- Voluntary Action Indicated (VAI)Mar 15, 2024
Postmarket Assurance: Devices · Citations posted
Inspection citations
14 on file
Top cited requirements
Compare to industry ↗21 CFR 820.20(c)Management review - Lack of or inadequate procedures
121 CFR 820.22Quality audits - Lack of or inadequate procedures
121 CFR 820.25(b)Training - Lack of or inadequate procedures
121 CFR 820.30(j)Design history file
121 CFR 820.50Purchasing controls, Lack of or inadequate procedures
121 CFR 820.70(a)Process control procedures, Lack of or inadequate procedures
1
- 21 CFR 820.20(c)Mar 15, 2024
Management review - Lack of or inadequate procedures
- 21 CFR 820.22Mar 15, 2024
Quality audits - Lack of or inadequate procedures
- 21 CFR 820.25(b)Mar 15, 2024
Training - Lack of or inadequate procedures
- 21 CFR 820.30(j)Mar 15, 2024
Design history file
- 21 CFR 820.50Mar 15, 2024
Purchasing controls, Lack of or inadequate procedures
- 21 CFR 820.70(a)Mar 15, 2024
Process control procedures, Lack of or inadequate procedures
- 21 CFR 820.70(c)Mar 15, 2024
Environmental control Lack of or inadequate procedures
- 21 CFR 820.72(a)Mar 15, 2024
Calibration, Inspection, etc. Procedures Lack of or Inadequ
- 21 CFR 820.80(b)Mar 15, 2024
Lack of or inadequate receiving acceptance procedures
- 21 CFR 820.90(a)Mar 15, 2024
Nonconforming product, Lack of or inadequate procedures
- 21 CFR 820.100(a)Mar 15, 2024
Lack of or inadequate procedures
- 21 CFR 820.184Mar 15, 2024
Lack of or inadequate DHR procedures
- 21 CFR 820.198(a)Mar 15, 2024
Lack of or inadequate complaint procedures
- 21 CFR 820.198(e)Mar 15, 2024
Records of complaint investigation
Compliance actions
0 on file
No warning letters or injunctions on file for this FEI number.
Import refusals
0 on file
No import refusals on file for this FEI number.