FDA Inspection
Biomat USA, IncBiomat USA, Inc – FDA Inspection, Apr 26, 2011
Record Details
This FDA Inspection record concerns Biomat USA, Inc, with an inspection on April 26, 2011, issued by the Center for Biologics Evaluation and Research, covering biologics.
- Company
- Biomat USA, Inc
- Inspection Date
- April 26, 2011
- Product Type
- Biologics
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ID · 6ee7fbd6-b3c2-4d2e-904f-02bc6572373c
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 719763
- FDA center
- Biologics
- Project area
- Blood and Blood Products
FDA Citations
2- 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
4| Date | Classification | Office | Project area |
|---|---|---|---|
| January 9, 2020 | NAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
| January 27, 2017 | NAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
| July 28, 2014 | NAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
| July 10, 2009 | NAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
Other documents for Biomat USA, Inc
- FDA Inspection 1122860 - 2020-01-09
- FDA Inspection 998944 - 2017-01-27
- FDA Inspection 889867 - 2014-07-28
- FDA Inspection 599951 - 2009-07-10
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