FDA Inspection
Biomat USA IncBiomat USA Inc – FDA Inspection, Oct 5, 2017
Record Details
This FDA Inspection record concerns Biomat USA Inc, with an inspection on October 5, 2017, issued by the Center for Biologics Evaluation and Research, covering biologics.
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ID · 7c00e2d6-f09a-4b16-8f9f-76b2f27916f8
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1027767
- FDA center
- Biologics
- Project area
- Blood and Blood Products
- Outcome
- Form 483 issued
FDA Citations
1- 21 CFR 640.64(e)Prevention of contamination
Full citation text and observation details available on the Dashboard.
Other FDA inspections of Biomat USA Inc
5| Date | Classification | Office | Project area |
|---|---|---|---|
| January 30, 2020 | NAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
| June 17, 2015 | NAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
| September 19, 2013 | NAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
| August 16, 2012 | VAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
| February 11, 2010 | NAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
Other documents for Biomat USA Inc
- FDA Inspection 1118882 - 2020-01-30
- FDA Inspection 930472 - 2015-06-17
- FDA Inspection 849552 - 2013-09-19
- FDA Inspection 794880 - 2012-08-16
- FDA Inspection 655320 - 2010-02-11
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