FDA Inspection
Biomat USA, Inc.Biomat USA, Inc. – FDA Inspection, Aug 28, 2009
Record Details
This FDA Inspection record concerns Biomat USA, Inc., with an inspection on August 28, 2009, issued by the Center for Biologics Evaluation and Research, covering biologics.
- Company
- Biomat USA, Inc.
- Inspection Date
- August 28, 2009
- Product Type
- Biologics
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ID · 4e30d572-b764-410b-9955-a21958825e80
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 611515
- FDA center
- Biologics
- Project area
- Blood and Blood Products
FDA Citations
2- 21 CFR 640.31Donor eligibility
- 21 CFR 606.100(b)Establish, maintain and follow manufacturing SOPs
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Other FDA inspections of Biomat USA, Inc.
6| Date | Classification | Office | Project area |
|---|---|---|---|
| March 30, 2022 | NAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
| October 26, 2018 | NAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
| October 31, 2016 | NAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
| October 27, 2014 | NAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
| October 23, 2013 | NAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
Other documents for Biomat USA, Inc.
- FDA Inspection 1166510 - 2022-03-30
- FDA Inspection 1073794 - 2018-10-26
- FDA Inspection 996830 - 2016-10-31
- FDA Inspection 901811 - 2014-10-27
- FDA Inspection 852533 - 2013-10-23
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