FDA Inspection
Biomat USA, IncBiomat USA, Inc – FDA Inspection, Dec 3, 2018
Record Details
This FDA Inspection record concerns Biomat USA, Inc, with an inspection on December 3, 2018, issued by the Center for Biologics Evaluation and Research, covering biologics.
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ID · dc9ee5c3-dbdc-40a7-843d-a31698f5b5c2
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1073344
- FDA center
- Biologics
- Project area
- Blood and Blood Products
- Outcome
- Form 483 issued
FDA Citations
4- 21 CFR 630.40(a)Supplemental results
- 21 CFR 606.171Biological product deviation report
- 21 CFR 600.12(a)Maintenance - tracing
- 21 CFR 600.11(b)Equipment
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Other FDA inspections of Biomat USA, Inc
5| Date | Classification | Office | Project area |
|---|---|---|---|
| July 23, 2021 | NAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
| September 14, 2016 | NAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
| August 21, 2014 | NAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
| June 6, 2012 | NAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
| March 19, 2010 | NAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
Other documents for Biomat USA, Inc
- FDA Inspection 1149030 - 2021-07-23
- FDA Inspection 984570 - 2016-09-14
- FDA Inspection 892304 - 2014-08-21
- FDA Inspection 783979 - 2012-06-06
- FDA Inspection 654445 - 2010-03-19
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