FDA Inspection
Barcode Automation, Inc.Barcode Automation, Inc. – FDA Inspection, May 18, 2010
Record Details
This FDA Inspection record concerns Barcode Automation, Inc., with an inspection on May 18, 2010, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- Barcode Automation, Inc.
- Inspection Date
- May 18, 2010
- Product Type
- Devices
View Company Profile
ID · 2265350a-5757-4884-99cd-5ff3ff7e5e13
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 662158
- FDA center
- Medical Devices & Rad Health
- Project area
- Radiation Control and Health Safety Act
FDA Citations
6- 21 CFR 1040.10(f)(2)(iii)(b)No multiple safety interlocks for Class II emission limits
- 21 CFR 1040.10(g)(9)Label locations
- 21 CFR 1040.10(f)(5)(i)Emission indicator - Class II & IIIa
- 21 CFR 1010.3(a)(1)ID label lacks name and address
- 21 CFR 1040.10(g)(7)(i)DIPH label wording - Class II
- 21 CFR 1040.10(g)(5)(i)Aperture label - laser radiation
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Other FDA inspections of Barcode Automation, Inc.
1| Date | Classification | Office | Project area |
|---|---|---|---|
| December 13, 2018 | VAI | Center for Devices and Radiological Health | Radiation Control and Health Safety Act |
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