FDA Inspection
Biomat USA Inc.Biomat 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.
- Person
- Leeterry Moore (Issuing Officer)
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ID · d68781ad-9e74-4fa7-83ce-dd8428cf037a
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1063223
- FDA center
- Biologics
- Project area
- Blood and Blood Products
- Outcome
- Form 483 issued
FDA Citations
1- 21 CFR 606.171Biological product deviation report
Full citation text and observation details available on the Dashboard.
Other FDA inspections of Biomat USA Inc.
3| Date | Classification | Office | Project area |
|---|---|---|---|
| June 28, 2024 | NAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
| July 20, 2015 | NAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
| June 21, 2011 | VAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
Other documents for Biomat USA Inc.
- FDA Inspection 1243015 - 2024-06-28
- FDA Inspection 935765 - 2015-07-20
- FDA Inspection 730999 - 2011-06-21
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