FDA Inspection
Allied Vision Group IncAllied Vision Group Inc – FDA Inspection, Dec 11, 2018
Record Details
This FDA Inspection record concerns Allied Vision Group Inc, with an inspection on December 11, 2018, issued by the Center for Devices and Radiological Health, covering devices.
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ID · 8c7b6d66-7dd5-4d1f-96e0-d40a112b7af0
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 1074131
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
- Outcome
- Form 483 issued
FDA Citations
6- 21 CFR 820.160(b)Distribution 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 820.150Lack of or inadequate procedures for storage.
- 21 CFR 803.17Lack of Written MDR Procedures
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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 |
| November 21, 2019 | OAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
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