711732
Ascension St. Mary's Hospital — FEI 1000041176
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- February 4, 2011
- Fiscal Year
- 2011
- Product Type
- Biologics
- Project Area
- Blood and Blood Products
- Location
- Saginaw, MI (United States)
Citations
| ID | CFR | Description |
|---|
| 154 | 21 CFR 606.160(a)(1) | Concurrent documentation |
| 159 | 21 CFR 606.160(a)(1) | Legibility and indelibility |
| 76 | 21 CFR 606.100(b) | Establish, maintain and follow manufacturing SOPs |
| 82 | 21 CFR 606.100(b)(3) | Preparation of phlebotomy site |
| 9044 | 21 CFR 600.10(b) | Personnel capabilities |
| 94 | 21 CFR 606.100(b)(15) | Schedules and procedures for equipment & calibration |