FDA Inspection 683675 — DynaRad X-Ray, LLC
The FDA completed an inspection of DynaRad X-Ray, LLC on Sep 30, 2010 in Boca Raton, 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
- Sep 30, 2010
- Fiscal Year
- 2010
- Product Type
- Devices
- Project Area
- Radiation Control and Health Safety Act
- Location
- Boca Raton, FL (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 2350 | 21 CFR 820.25(b) | Training - Lack of or inadequate procedures |
| 5005 | 21 CFR 1002.11 | Failure to submit |