FDA Inspection 803415 — Radnostix
The FDA completed an inspection of Radnostix on October 19, 2012 in Idaho Falls, ID. 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: Drugs.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- October 19, 2012
- Fiscal Year
- 2013
- Product Type
- Drugs
- Project Area
- Unapproved and Misbranded Drugs
- Location
- Idaho Falls, ID (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1098 | 21 CFR 211.22(c) | Approve or reject procedures or specs |
| 1774 | 21 CFR 211.142(a) | Quarantine - actual practice |
| 1914 | 21 CFR 211.166(a) | Lack of written stability program |
| 4314 | 21 CFR 211.84(d)(2) | Reports of Analysis (Components) |