FDA Inspection
Barcode Automation, Inc.Barcode Automation, Inc. – FDA Inspection, Dec 13, 2018
Record Details
This FDA Inspection record concerns Barcode Automation, Inc., with an inspection on December 13, 2018, issued by the Center for Devices and Radiological Health, covering devices.
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ID · e7f8e766-b664-4f22-abac-e9543448120e
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1074419
- FDA center
- Medical Devices & Rad Health
- Project area
- Radiation Control and Health Safety Act
- Outcome
- Form 483 issued
FDA Citations
2- 21 CFR 1040.10(g)(6)(iv)NIPH label wording - Class IIIb
- 21 CFR 1040.10(h)(1)(iii)Legible reproductions
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Other FDA inspections of Barcode Automation, Inc.
1| Date | Classification | Office | Project area |
|---|---|---|---|
| May 18, 2010 | VAI | Center for Devices and Radiological Health | Radiation Control and Health Safety Act |
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