FDA Inspection 706914 — Corewell Health William Beaumont University Hospital
The FDA completed an inspection of Corewell Health William Beaumont University Hospital on January 25, 2011 in Royal Oak, 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
- January 25, 2011
- Fiscal Year
- 2011
- Product Type
- Biologics
- Project Area
- Blood and Blood Products
- Location
- Royal Oak, MI (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 76 | 21 CFR 606.100(b) | Establish, maintain and follow manufacturing SOPs |
| 9044 | 21 CFR 600.10(b) | Personnel capabilities |