FDA Inspection 636435 — Grifols Bio Supplies Inc
The FDA completed an inspection of Grifols Bio Supplies Inc on December 10, 2009 in Memphis, TN. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 7 citations were issued during this inspection. Product area: Biologics.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- December 10, 2009
- Fiscal Year
- 2010
- Product Type
- Biologics
- Project Area
- Blood and Blood Products
- Location
- Memphis, TN (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 15030 | 21 CFR 606.60(b) | Equipment calibration frequency |
| 225 | 21 CFR 640.4(f) | Closed system |
| 31 | 21 CFR 606.20(b) | Qualifications of responsible personnel |
| 67 | 21 CFR 606.65(e) | Following manufacturer's instructions |
| 77 | 21 CFR 606.100(b) | Written SOPs available for use by personnel |
| 86 | 21 CFR 606.100(b)(7) | Methods for performance of all tests |
| 94 | 21 CFR 606.100(b)(15) | Schedules and procedures for equipment & calibration |