FDA Inspection
Biomat USA, IncBiomat USA, Inc – FDA Inspection, Feb 15, 2017
Record Details
This FDA Inspection record concerns Biomat USA, Inc, with an inspection on February 15, 2017, issued by the Center for Biologics Evaluation and Research, covering biologics.
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ID · 82636e11-2464-4a63-a53b-6e722a714f41
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1005674
- FDA center
- Biologics
- Project area
- Blood and Blood Products
- Outcome
- Form 483 issued
FDA Citations
3- 21 CFR 606.100(c)Thorough investigations
- 21 CFR 211.22(a)Authority lacking to review records, investigate errors
- 21 CFR 606.100(b)Establish, maintain and follow manufacturing SOPs
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Other FDA inspections of Biomat USA, Inc
5| Date | Classification | Office | Project area |
|---|---|---|---|
| October 25, 2024 | NAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
| February 4, 2015 | NAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
| December 7, 2012 | VAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
| January 12, 2011 | NAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
| February 19, 2009 | VAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
Other documents for Biomat USA, Inc
- FDA Inspection 1253778 - 2024-10-25
- FDA Inspection 912526 - 2015-02-04
- FDA Inspection 808445 - 2012-12-07
- FDA Inspection 706602 - 2011-01-12
- FDA Inspection 562135 - 2009-02-19
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