FDA Inspection
Allied Vision Group IncAllied Vision Group Inc – FDA Inspection, Nov 21, 2019
Record Details
This FDA Inspection record concerns Allied Vision Group Inc, with an inspection on November 21, 2019, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- Allied Vision Group Inc
- Inspection Date
- November 21, 2019
- Product Type
- Devices
View Company Profile
ID · 8f6cb385-caf3-4528-8a94-ed7852957c16
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 1110905
- FDA center
- Medical Devices & Rad Health
- Project area
- Postmarket Assurance: Devices
FDA Citations
9- 21 CFR 806.10(a)(1)Report of risk to health
- 21 CFR 820.160(b)Distribution records
- 21 CFR 820.25(b)Training records
- 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 820.90(a)Nonconforming product, Lack of or inadequate procedures
- 21 CFR 820.50(a)(1)Documented evaluation
- 21 CFR 803.17Lack of Written MDR Procedures
Full citation text and observation details available on the Dashboard.
Other FDA inspections of Allied Vision Group Inc
2| Date | Classification | Office | Project area |
|---|---|---|---|
| April 22, 2022 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
| December 11, 2018 | OAI | Center for Devices and Radiological Health | Compliance: Devices |
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