FDA Inspection
Biomat USA IncBiomat USA Inc – FDA Inspection, Aug 24, 2018
Record Details
This FDA Inspection record concerns Biomat USA Inc, with an inspection on August 24, 2018, issued by the Center for Biologics Evaluation and Research, covering biologics.
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ID · 059962c2-b91a-4197-b679-f4fb7a9034ef
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1063182
- 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
5| Date | Classification | Office | Project area |
|---|---|---|---|
| June 23, 2022 | NAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
| June 30, 2015 | NAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
| September 27, 2013 | NAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
| August 17, 2011 | NAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
| February 1, 2010 | VAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
Other documents for Biomat USA Inc
- FDA Inspection 1173782 - 2022-06-23
- FDA Inspection 932372 - 2015-06-30
- FDA Inspection 850538 - 2013-09-27
- FDA Inspection 739997 - 2011-08-17
- FDA Inspection 642601 - 2010-02-01
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