FDA Inspection
Biomat USA IncBiomat USA Inc – FDA Inspection, Sep 8, 2016
Record Details
This FDA Inspection record concerns Biomat USA Inc, with an inspection on September 8, 2016, issued by the Center for Biologics Evaluation and Research, covering biologics.
- Company
- Biomat USA Inc
- Inspection Date
- September 8, 2016
- Product Type
- Biologics
View Company Profile
ID · da186fbb-90f3-4da3-a09b-1f4f0a67ea8c
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 986833
- FDA center
- Biologics
- Project area
- Blood and Blood Products
FDA Citations
1- 21 CFR 606.100(b)Establish, maintain and follow manufacturing SOPs
Full citation text and observation details available on the Dashboard.
Other FDA inspections of Biomat USA Inc
4| Date | Classification | Office | Project area |
|---|---|---|---|
| October 26, 2018 | NAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
| November 20, 2013 | VAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
| December 7, 2011 | NAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
| October 7, 2009 | NAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
Other documents for Biomat USA Inc
- FDA Inspection 1072393 - 2018-10-26
- FDA Inspection 855772 - 2013-11-20
- FDA Inspection 760556 - 2011-12-07
- FDA Inspection 621105 - 2009-10-07
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