FDA Inspection
Biomat USA, Inc.Biomat USA, Inc. – FDA Inspection, Sep 3, 2015
Record Details
This FDA Inspection record concerns Biomat USA, Inc., with an inspection on September 3, 2015, issued by the Center for Biologics Evaluation and Research, covering biologics.
- Company
- Biomat USA, Inc.
- Inspection Date
- September 3, 2015
- Product Type
- Biologics
View Company Profile
ID · bb94bca3-932f-47f7-a0db-8bb6f3082d16
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 965172
- FDA center
- Biologics
- Project area
- Blood and Blood Products
FDA Citations
3- 21 CFR 606.160(b)Required records
- 21 CFR 630.40(b)(1)Deferred or not eligible
- 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 |
|---|---|---|---|
| June 4, 2018 | NAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
| March 30, 2012 | NAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
| September 14, 2009 | NAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
Other documents for Biomat USA, Inc.
- FDA Inspection 1056228 - 2018-06-04
- FDA Inspection 774403 - 2012-03-30
- FDA Inspection 619868 - 2009-09-14
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