FDA Inspection
Biomat USA IncBiomat USA Inc – FDA Inspection, Sep 20, 2011
Record Details
This FDA Inspection record concerns Biomat USA Inc, with an inspection on September 20, 2011, issued by the Center for Biologics Evaluation and Research, covering biologics.
- Company
- Biomat USA Inc
- Inspection Date
- September 20, 2011
- Product Type
- Biologics
View Company Profile
ID · e16e29e3-1ccb-4b62-a639-68d55150a762
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 746815
- FDA center
- Biologics
- Project area
- Blood and Blood Products
FDA Citations
3- 21 CFR 600.10(b)Personnel capabilities
- 21 CFR 640.67Laboratory tests
- 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 |
|---|---|---|---|
| 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 17, 2014 | 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 896180 - 2014-09-17
- FDA Inspection 576969 - 2009-04-21
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