FDA Inspection 881586 — Scantibodies Laboratory, Inc.
The FDA completed an inspection of Scantibodies Laboratory, Inc. on June 16, 2014 in Santee, CA. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 8 citations were issued during this inspection. Product area: Biologics.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- June 16, 2014
- Fiscal Year
- 2014
- Product Type
- Biologics
- Project Area
- Blood and Blood Products
- Location
- Santee, CA (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 31 | 21 CFR 606.20(b) | Qualifications of responsible personnel |
| 3244 | 21 CFR 640.61 | Written consent |
| 338 | 21 CFR 640.65(b)(2)(i) | Physician review of four month sample |
| 343 | 21 CFR 640.65(b)(3) | Donor identification system |
| 3455 | 21 CFR 601.12(f)(1) | Labeling changes |
| 368 | 21 CFR 640.72(d) | Donor reaction |
| 76 | 21 CFR 606.100(b) | Establish, maintain and follow manufacturing SOPs |
| 78 | 21 CFR 606.100(c) | Record review prior to release |