FDA Inspection 607733 — IBT Scientific Llc
The FDA completed an inspection of IBT Scientific Llc on August 7, 2009 in Elkhart, IN. The inspection was classified NAI (No Action Indicated — no objectionable conditions were found). 3 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- No Action Indicated (NAI) (NAI)
- End Date
- August 7, 2009
- Fiscal Year
- 2009
- Product Type
- Devices
- Project Area
- Postmarket Assurance: Devices
- Location
- Elkhart, IN (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 3127 | 21 CFR 820.80(e) | Documentation |
| 3332 | 21 CFR 820.184(e) | ID label, labeling |
| 546 | 21 CFR 820.75(a) | Lack of or inadequate process validation |