FDA Inspection 662158 — Barcode Automation, Inc.
The FDA completed an inspection of Barcode Automation, Inc. on May 18, 2010 in Winter Springs, FL. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions or practices were found, but the agency is not prepared to take or recommend any administrative or regulatory action). 6 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- May 18, 2010
- Fiscal Year
- 2010
- Product Type
- Devices
- Project Area
- Radiation Control and Health Safety Act
- Location
- Winter Springs, FL (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 5043 | 21 CFR 1010.3(a)(1) | ID label lacks name and address |
| 5147 | 21 CFR 1040.10(f)(2)(iii)(b) | No multiple safety interlocks for Class II emission limits |
| 5152 | 21 CFR 1040.10(f)(5)(i) | Emission indicator - Class II & IIIa |
| 5173 | 21 CFR 1040.10(g)(5)(i) | Aperture label - laser radiation |
| 5185 | 21 CFR 1040.10(g)(7)(i) | DIPH label wording - Class II |
| 5194 | 21 CFR 1040.10(g)(9) | Label locations |