FDA Inspection
Biomat USA, Inc.Biomat USA, Inc. – FDA Inspection, Feb 1, 2018
Record Details
This FDA Inspection record concerns Biomat USA, Inc., with an inspection on February 1, 2018, issued by the Center for Biologics Evaluation and Research, covering biologics.
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ID · c0373e11-1ba4-4db2-9682-283a58cb0d52
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1039319
- 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
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Other FDA inspections of Biomat USA, Inc.
3| Date | Classification | Office | Project area |
|---|---|---|---|
| March 24, 2023 | NAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
| June 13, 2013 | VAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
| September 28, 2011 | VAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
Other documents for Biomat USA, Inc.
- FDA Inspection 1201080 - 2023-03-24
- FDA Inspection 835567 - 2013-06-13
- FDA Inspection 747161 - 2011-09-28
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