1099142
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- August 9, 2019
- Fiscal Year
- 2019
- Product Type
- Biologics
- Project Area
- Blood and Blood Products
- Location
- South Bend, IN (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 12203 | 21 CFR 606.170(a) | Adverse Reaction- Reports of Investigations |
| 12371 | 21 CFR 1271.200(a) | Cleaned, sanitized per established schedules |
| 4425 | 21 CFR 606.60(a) | Equipment observed, standardized, calibrated |