FDA Inspection
Biomat USA IncBiomat USA Inc – FDA Inspection, Jul 17, 2009
Record Details
This FDA Inspection record concerns Biomat USA Inc, with an inspection on July 17, 2009, issued by the Center for Biologics Evaluation and Research, covering biologics.
- Company
- Biomat USA Inc
- Inspection Date
- July 17, 2009
- Product Type
- Biologics
View Company Profile
ID · 30d06644-4c7d-48a5-ad42-d70f83585363
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 606686
- FDA center
- Biologics
- Project area
- Blood and Blood Products
FDA Citations
2- 21 CFR 606.160(e)(1)Donor deferral record - each location
- 21 CFR 606.100(b)Establish, maintain and follow manufacturing SOPs
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Other FDA inspections of Biomat USA Inc
3| Date | Classification | Office | Project area |
|---|---|---|---|
| October 2, 2017 | VAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
| January 14, 2013 | VAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
| April 28, 2011 | VAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
Other documents for Biomat USA Inc
- FDA Inspection 1028241 - 2017-10-02
- FDA Inspection 815098 - 2013-01-14
- FDA Inspection 724917 - 2011-04-28
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