FDA Inspection
Paradigm Bio Devices Inc.Paradigm Bio Devices Inc. – FDA Inspection, Apr 14, 2016
Record Details
This FDA Inspection record concerns Paradigm Bio Devices Inc., with an inspection on April 14, 2016, issued by the Center for Biologics Evaluation and Research, covering biologics.
- Company
- Paradigm Bio Devices Inc.
- Inspection Date
- April 14, 2016
- Product Type
- Biologics
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ID · db95b0ab-c7d8-44f3-bded-e62e956dd733
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 968163
- FDA center
- Biologics
- Project area
- Human Cellular, Tissue, and Gene Therapies
FDA Citations
2- 21 CFR 1271.260(e)Temperature limits
- 21 CFR 1271.260(e)Storage temperatures recorded, maintained
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Other FDA inspections of Paradigm Bio Devices Inc.
2| Date | Classification | Office | Project area |
|---|---|---|---|
| June 3, 2013 | NAI | Center for Biologics Evaluation and Research | Human Cellular, Tissue, and Gene Therapies |
| June 29, 2012 | VAI | Center for Biologics Evaluation and Research | Human Cellular, Tissue, and Gene Therapies |
Other documents for Paradigm Bio Devices Inc.
- FDA Inspection 834206 - 2013-06-03
- FDA Inspection 792110 - 2012-06-29
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