FDA Inspection 738851 — Radix Acquisition Company, LLC
The FDA completed an inspection of Radix Acquisition Company, LLC on August 2, 2011 in Eau Claire, WI. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 6 citations were issued during this inspection. Product area: Veterinary.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- August 2, 2011
- Fiscal Year
- 2011
- Product Type
- Veterinary
- Project Area
- Monitoring of Marketed Animal Drugs, Feed, and Devices
- Location
- Eau Claire, WI (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1105 | 21 CFR 211.22(d) | Procedures not in writing, fully followed |
| 1133 | 21 CFR 211.25(a) | GMP Training Frequency |
| 1177 | 21 CFR 211.63 | Equipment Design, Size and Location |
| 1722 | 21 CFR 211.134(a) | Correct labels during finishing operations |
| 1790 | 21 CFR 211.80(b) | Handling and Storage to Prevent Contamination |
| 1920 | 21 CFR 211.166(a)(3) | Valid stability test methods |