FDA Inspection 557227 — Eversight Illinois, Bloomington
The FDA completed an inspection of Eversight Illinois, Bloomington on Jan 29, 2009 in Bloomington, IL. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions or practices were found, but the agency is not prepared to take or recommend any administrative or regulatory action). 5 citations were issued during this inspection. Product area: Biologics.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Jan 29, 2009
- Fiscal Year
- 2009
- Product Type
- Biologics
- Project Area
- Human Cellular, Tissue, and Gene Therapies
- Location
- Bloomington, IL (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 12320 | 21 CFR 1271.160(b)(3) | Actions verified, short and long term solutions |
| 12339 | 21 CFR 1271.180(c) | Availability of procedures |
| 12363 | 21 CFR 1271.195(c) | Monitoring--cross contamination, exposure to CD |
| 12379 | 21 CFR 1271.210(d)(1) | Receipt documentation elements |
| 12473 | 21 CFR 1271.350(b)(2) | Deviations not reported to FDA |