FDA Inspection
Biomat USA Inc.Biomat USA Inc. – FDA Inspection, Jun 27, 2012
Record Details
This FDA Inspection record concerns Biomat USA Inc., with an inspection on June 27, 2012, issued by the Center for Biologics Evaluation and Research, covering biologics.
- Company
- Biomat USA Inc.
- Inspection Date
- June 27, 2012
- Product Type
- Biologics
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ID · a3c8ad1f-2af4-4dc5-be8d-26da8fdbece6
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 787742
- FDA center
- Biologics
- Project area
- Blood and Blood Products
FDA Citations
2- 21 CFR 640.31Donor eligibility
- 21 CFR 606.100(b)Establish, maintain and follow manufacturing SOPs
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Other FDA inspections of Biomat USA Inc.
6| Date | Classification | Office | Project area |
|---|---|---|---|
| March 13, 2025 | Not classified | Cincinnati District Office | |
| September 23, 2019 | NAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
| February 10, 2017 | NAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
| November 10, 2014 | NAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
| April 15, 2011 | NAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
Other documents for Biomat USA Inc.
- FDA Inspection 1264000 - 2025-03-13
- FDA Inspection 1103055 - 2019-09-23
- FDA Inspection 1001133 - 2017-02-10
- FDA Inspection 903062 - 2014-11-10
- FDA Inspection 719999 - 2011-04-15
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