FDA Inspection
Biomat USA, Inc.Biomat USA, Inc. – FDA Inspection, Jan 15, 2010
Record Details
This FDA Inspection record concerns Biomat USA, Inc., with an inspection on January 15, 2010, issued by the Center for Biologics Evaluation and Research, covering biologics.
- Company
- Biomat USA, Inc.
- Inspection Date
- January 15, 2010
- Product Type
- Biologics
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ID · 821084c7-beb0-4101-8721-a8656233b849
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 638921
- FDA center
- Biologics
- Project area
- Blood and Blood Products
FDA Citations
3- 21 CFR 606.100(c)Thorough investigations
- 21 CFR 606.171Biological product deviation report
- 21 CFR 606.100(b)Establish, maintain and follow manufacturing SOPs
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Other FDA inspections of Biomat USA, Inc.
2| Date | Classification | Office | Project area |
|---|---|---|---|
| September 20, 2018 | NAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
| February 2, 2012 | NAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
Other documents for Biomat USA, Inc.
- FDA Inspection 1067687 - 2018-09-20
- FDA Inspection 770062 - 2012-02-02
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