FDA Inspection
Biomat USA IncBiomat USA Inc – FDA Inspection, Sep 17, 2014
Record Details
This FDA Inspection record concerns Biomat USA Inc, with an inspection on September 17, 2014, issued by the Center for Biologics Evaluation and Research, covering biologics.
- Company
- Biomat USA Inc
- Inspection Date
- September 17, 2014
- Product Type
- Biologics
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ID · ac8bbbe0-cdc4-45ca-adca-f0fe6adfbaf2
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 896180
- FDA center
- Biologics
- Project area
- Blood and Blood Products
FDA Citations
2- 21 CFR 640.63(a)Determining donor suitability
- 21 CFR 606.171Biological product deviation report
Full citation text and observation details available on the Dashboard.
Other FDA inspections of Biomat USA Inc
4| Date | Classification | Office | Project area |
|---|---|---|---|
| February 15, 2018 | NAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
| May 20, 2016 | NAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
| September 20, 2011 | VAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
| April 21, 2009 | VAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
Other documents for Biomat USA Inc
- FDA Inspection 1049586 - 2018-02-15
- FDA Inspection 985568 - 2016-05-20
- FDA Inspection 746815 - 2011-09-20
- FDA Inspection 576969 - 2009-04-21
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