FDA Inspection
OraWell USAOraWell USA – FDA Inspection, Aug 5, 2011
Record Details
This FDA Inspection record concerns OraWell USA, with an inspection on August 5, 2011, issued by the Center for Biologics Evaluation and Research, covering biologics.
- Company
- OraWell USA
- Inspection Date
- August 5, 2011
- Product Type
- Biologics
View Company Profile
ID · cbcac30b-46dc-4fa5-adc5-bafa64ed3419
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 733405
- FDA center
- Biologics
- Project area
- Blood and Blood Products
FDA Citations
10- 21 CFR 820.181DMR - not or inadequately maintained
- 21 CFR 820.20(d)Quality plan
- 21 CFR 820.30(b)Design plans - Lack of or inadequate
- 21 CFR 820.40Lack of procedures, or not maintained
- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.184Lack of or inadequate DHR procedures
- 21 CFR 820.198(a)Lack of or inadequate complaint procedures
- 21 CFR 820.70(a)Process control procedures, Lack of or inadequate procedures
- 21 CFR 820.50(b)Approval, inadequate purchasing data
- 21 CFR 820.20(a)Quality policy and objectives
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Other FDA inspections of OraWell USA
1| Date | Classification | Office | Project area |
|---|---|---|---|
| December 15, 2011 | NAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
Other documents for OraWell USA
- FDA Inspection 762285 - 2011-12-15
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