FDA Inspection
Biomat USA, IncBiomat USA, Inc – FDA Inspection, Oct 22, 2009
Record Details
This FDA Inspection record concerns Biomat USA, Inc, with an inspection on October 22, 2009, issued by the Center for Biologics Evaluation and Research, covering biologics.
- Company
- Biomat USA, Inc
- Inspection Date
- October 22, 2009
- Product Type
- Biologics
View Company Profile
ID · 9ef2f9cf-dee7-4751-91be-ae6f64582572
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 626356
- FDA center
- Biologics
- Project area
- Blood and Blood Products
FDA Citations
2- 21 CFR 600.10(b)Personnel capabilities
- 21 CFR 640.31Donor eligibility
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Other FDA inspections of Biomat USA, Inc
4| Date | Classification | Office | Project area |
|---|---|---|---|
| June 21, 2019 | NAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
| January 13, 2016 | NAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
| February 27, 2014 | NAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
| October 26, 2011 | VAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
Other documents for Biomat USA, Inc
- FDA Inspection 1098274 - 2019-06-21
- FDA Inspection 960815 - 2016-01-13
- FDA Inspection 867833 - 2014-02-27
- FDA Inspection 761209 - 2011-10-26
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