FDA Inspection
Paradigm Bio Devices Inc.Paradigm Bio Devices Inc. – FDA Inspection, Jun 29, 2012
Record Details
This FDA Inspection record concerns Paradigm Bio Devices Inc., with an inspection on June 29, 2012, issued by the Center for Biologics Evaluation and Research, covering biologics.
- Company
- Paradigm Bio Devices Inc.
- Inspection Date
- June 29, 2012
- Product Type
- Biologics
View Company Profile
ID · d0f6f043-4b8a-451d-95c9-95d4c7d42746
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 792110
- FDA center
- Biologics
- Project area
- Human Cellular, Tissue, and Gene Therapies
FDA Citations
17- 21 CFR 820.181DMR - not or inadequately maintained
- 21 CFR 820.20(d)Quality plan
- 21 CFR 820.198(a)Complaints
- 21 CFR 820.40Lack of procedures, or not maintained
- 21 CFR 820.20(c)Management review - defined interval, sufficient frequency
- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 1271.265(f)Return to inventory--procedures
- 21 CFR 820.184Lack of or inadequate DHR procedures
- 21 CFR 820.80(d)Lack of or inadequate final acceptance procedures
- 21 CFR 820.25(b)Training - Lack of or inadequate procedures
Showing 10 of 17 citations.
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Other FDA inspections of Paradigm Bio Devices Inc.
2| Date | Classification | Office | Project area |
|---|---|---|---|
| April 14, 2016 | VAI | Center for Biologics Evaluation and Research | Human Cellular, Tissue, and Gene Therapies |
| June 3, 2013 | NAI | Center for Biologics Evaluation and Research | Human Cellular, Tissue, and Gene Therapies |
Other documents for Paradigm Bio Devices Inc.
- FDA Inspection 968163 - 2016-04-14
- FDA Inspection 834206 - 2013-06-03
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