FDA Inspection
Scantibodies Laboratory, Inc.Scantibodies Laboratory, Inc. – FDA Inspection, Jun 16, 2014
Record Details
This FDA Inspection record concerns Scantibodies Laboratory, Inc., with an inspection on June 16, 2014, issued by the Center for Biologics Evaluation and Research, covering biologics.
- Inspection Date
- June 16, 2014
- Product Type
- Biologics
View Company Profile
ID · 09113afa-03a5-4481-b686-736e8de6f969
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 881586
- FDA center
- Biologics
- Project area
- Blood and Blood Products
FDA Citations
8- 21 CFR 606.100(c)Record review prior to release
- 21 CFR 640.72(d)Donor reaction
- 21 CFR 640.65(b)(2)(i)Physician review of four month sample
- 21 CFR 640.65(b)(3)Donor identification system
- 21 CFR 640.61Written consent
- 21 CFR 601.12(f)(1)Labeling changes
- 21 CFR 606.20(b)Qualifications of responsible personnel
- 21 CFR 606.100(b)Establish, maintain and follow manufacturing SOPs
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Other FDA inspections of Scantibodies Laboratory, Inc.
5| Date | Classification | Office | Project area |
|---|---|---|---|
| July 2, 2026 | Not classified | Los Angeles District Office | Blood and Blood Products |
| March 14, 2019 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
| May 24, 2013 | OAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
| December 19, 2011 | NAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
| November 21, 2011 | NAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
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