FDA Inspection 1074419 — Barcode Automation, Inc.
The FDA completed an inspection of Barcode Automation, Inc. on Dec 13, 2018 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). 2 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Dec 13, 2018
- Fiscal Year
- 2019
- Product Type
- Devices
- Project Area
- Radiation Control and Health Safety Act
- Location
- Winter Springs, FL (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 5180 | 21 CFR 1040.10(g)(6)(iv) | NIPH label wording - Class IIIb |
| 5199 | 21 CFR 1040.10(h)(1)(iii) | Legible reproductions |