FDA Inspection 908695 — ITxM Clinical Services
The FDA completed an inspection of ITxM Clinical Services on January 29, 2015 in Rosemont, IL. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 3 citations were issued during this inspection. Product area: Biologics.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- January 29, 2015
- Fiscal Year
- 2015
- Product Type
- Biologics
- Project Area
- Blood and Blood Products
- Location
- Rosemont, IL (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 155 | 21 CFR 606.160(b) | Required records |
| 94 | 21 CFR 606.100(b)(15) | Schedules and procedures for equipment & calibration |
| 98 | 21 CFR 606.100(c) | Thorough investigations |