FDA Inspection
Biomat USA IncBiomat USA Inc – FDA Inspection, Oct 2, 2017
Record Details
This FDA Inspection record concerns Biomat USA Inc, with an inspection on October 2, 2017, issued by the Center for Biologics Evaluation and Research, covering biologics.
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ID · db3cc610-3c22-420e-bbc8-69926c9a4198
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1028241
- FDA center
- Biologics
- Project area
- Blood and Blood Products
- Outcome
- Form 483 issued
FDA Citations
2- 21 CFR 600.14(c)When to report
- 21 CFR 606.100(b)Establish, maintain and follow manufacturing SOPs
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Other FDA inspections of Biomat USA Inc
3| Date | Classification | Office | Project area |
|---|---|---|---|
| January 14, 2013 | VAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
| April 28, 2011 | VAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
| July 17, 2009 | VAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
Other documents for Biomat USA Inc
- FDA Inspection 815098 - 2013-01-14
- FDA Inspection 724917 - 2011-04-28
- FDA Inspection 606686 - 2009-07-17
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