FDA Inspection 735266 — Radnostix
The FDA completed an inspection of Radnostix on July 22, 2011 in Idaho Falls, ID. The inspection was classified OAI (Official Action Indicated — objectionable conditions were found and regulatory action is recommended). 20 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Official Action Indicated (OAI) (OAI)
- End Date
- July 22, 2011
- Fiscal Year
- 2011
- 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 |
| 1133 | 21 CFR 211.25(a) | GMP Training Frequency |
| 1215 | 21 CFR 211.67(b) | Written procedures not established/followed |
| 1227 | 21 CFR 211.67(c) | Cleaning/maintenance records not kept |
| 1361 | 21 CFR 211.100(a) | Absence of Written Procedures |
| 1450 | 21 CFR 211.113(a) | Procedures for non-sterile drug products |
| 1495 | 21 CFR 211.122(a) | Written procedures describing in detail |
| 1507 | 21 CFR 211.122(f) | Gang printed labeling |
| 1540 | 21 CFR 211.125(a) | Strict control not exercised over labeling issued |
| 1787 | 21 CFR 211.80(a) | Procedures To Be in Writing |
| 1801 | 21 CFR 211.84(a) | Components withheld from use pending release |
| 1833 | 21 CFR 211.84(d)(1) | Identity Testing of Each Component |
| 1883 | 21 CFR 211.165(a) | Testing and release for distribution |
| 1914 | 21 CFR 211.166(a) | Lack of written stability program |
| 2026 | 21 CFR 211.192 | Quality control unit review of records |
| 4314 | 21 CFR 211.84(d)(2) | Reports of Analysis (Components) |
| 4336 | 21 CFR 211.150 | Written distribution procedure |
| 4352 | 21 CFR 211.160(b)(4) | Calibration - at intervals, written program, remedial action |
| 4372 | 21 CFR 211.188(b)(8) | Labeling control records including specimens or copies |
| 4400 | 21 CFR 211.186(b)(8) | Description of containers, labels, et. al. |