FDA Inspection
Biomat USA IncBiomat USA Inc – FDA Inspection, Mar 6, 2009
Record Details
This FDA Inspection record concerns Biomat USA Inc, with an inspection on March 6, 2009, issued by the Center for Biologics Evaluation and Research, covering biologics.
- Company
- Biomat USA Inc
- Inspection Date
- March 6, 2009
- Product Type
- Biologics
View Company Profile
ID · 9e716fc5-1024-42da-bbb6-659b4fc71247
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 567091
- FDA center
- Biologics
- Project area
- Blood and Blood Products
FDA Citations
4- 21 CFR 606.121(e)(5)Required labeling information - Source Plasma
- 21 CFR 640.61Explanation of hazards
- 21 CFR 606.20(b)Qualifications of responsible personnel
- 21 CFR 606.100(b)(16)Labeling procedures to avoid labeling mix-ups
Full citation text and observation details available on the Dashboard.
Other FDA inspections of Biomat USA Inc
5| Date | Classification | Office | Project area |
|---|---|---|---|
| October 30, 2017 | NAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
| October 9, 2015 | NAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
| December 13, 2013 | VAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
| June 22, 2012 | NAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
| December 28, 2010 | VAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
Other documents for Biomat USA Inc
- FDA Inspection 1034809 - 2017-10-30
- FDA Inspection 945282 - 2015-10-09
- FDA Inspection 858689 - 2013-12-13
- FDA Inspection 787786 - 2012-06-22
- FDA Inspection 703347 - 2010-12-28
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