FDA Inspection
Biomat USA IncBiomat USA Inc – FDA Inspection, Jan 17, 2017
Record Details
This FDA Inspection record concerns Biomat USA Inc, with an inspection on January 17, 2017, issued by the Center for Biologics Evaluation and Research, covering biologics.
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ID · 8bd69529-c173-4523-bd83-b1ff714a37c2
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1001178
- FDA center
- Biologics
- Project area
- Blood and Blood Products
- Outcome
- Form 483 issued
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 |
|---|---|---|---|
| January 31, 2020 | NAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
| July 31, 2014 | NAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
| August 11, 2011 | NAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
| March 6, 2009 | NAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
Other documents for Biomat USA Inc
- FDA Inspection 1117469 - 2020-01-31
- FDA Inspection 889234 - 2014-07-31
- FDA Inspection 738928 - 2011-08-11
- FDA Inspection 569077 - 2009-03-06
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