FDA Inspection
Biomat USA, Inc.Biomat USA, Inc. – FDA Inspection, Jul 25, 2018
Record Details
This FDA Inspection record concerns Biomat USA, Inc., with an inspection on July 25, 2018, issued by the Center for Biologics Evaluation and Research, covering biologics.
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ID · 88ee4c1e-d39e-4966-bb4c-e447d6a7f126
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1059921
- 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 |
|---|---|---|---|
| February 27, 2025 | Not classified | Los Angeles District Office | |
| March 19, 2014 | NAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
| August 22, 2011 | VAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
Other documents for Biomat USA, Inc.
- FDA Inspection 1252470 - 2025-02-27
- FDA Inspection 872475 - 2014-03-19
- FDA Inspection 740512 - 2011-08-22
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