FDA Inspection 570563 — Prodigy Diabetes Care, LLC
The FDA completed an inspection of Prodigy Diabetes Care, LLC on January 27, 2009 in huntersville, NC. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 4 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- January 27, 2009
- Fiscal Year
- 2009
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- huntersville, NC (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 3127 | 21 CFR 820.80(e) | Documentation |
| 3371 | 21 CFR 820.198(a)(3) | Processing MDRs {see also 803, 804} |
| 3664 | 21 CFR 820.20(b)(2) | Training |
| 3696 | 21 CFR 820.100(b) | Documentation |