FDA Inspection 905464 — Corewell Health Dearborn Hospital
The FDA completed an inspection of Corewell Health Dearborn Hospital on December 2, 2014 in Dearborn, MI. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 2 citations were issued during this inspection. Product area: Biologics.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- December 2, 2014
- Fiscal Year
- 2015
- Product Type
- Biologics
- Project Area
- Blood and Blood Products
- Location
- Dearborn, MI (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 65 | 21 CFR 606.65(c) | Testing of representative samples of reagent lots |
| 76 | 21 CFR 606.100(b) | Establish, maintain and follow manufacturing SOPs |