FDA Inspection
Allied Biomedical Research Institute, Inc.Allied Biomedical Research Institute, Inc. – FDA Inspection, Sep 11, 2015
Record Details
This FDA Inspection record concerns Allied Biomedical Research Institute, Inc., with an inspection on September 11, 2015, issued by the Center for Biologics Evaluation and Research, covering biologics.
- Inspection Date
- September 11, 2015
- Product Type
- Biologics
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ID · cda1878d-afa4-481a-be4c-49e9b362c512
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 943168
- FDA center
- Biologics
- Project area
- Blood and Blood Products
FDA Citations
3- 21 CFR 606.121(e)Container label requirements - particular products
- 21 CFR 610.40(h)Shipment/use of reactive units, units from deferred donors
- 21 CFR 610.40(h)(2)(ii)Labeling of reactive units, units from deferred donors
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Other FDA inspections of Allied Biomedical Research Institute, Inc.
4| Date | Classification | Office | Project area |
|---|---|---|---|
| February 9, 2023 | NAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
| July 26, 2017 | NAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
| August 13, 2013 | NAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
| May 11, 2011 | NAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
Other documents for Allied Biomedical Research Institute, Inc.
- FDA Inspection 1197432 - 2023-02-09
- FDA Inspection 1026955 - 2017-07-26
- FDA Inspection 844004 - 2013-08-13
- FDA Inspection 724821 - 2011-05-11
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