FDA Inspection
Biomat USA Inc.Biomat USA Inc. – FDA Inspection, Feb 21, 2013
Record Details
This FDA Inspection record concerns Biomat USA Inc., with an inspection on February 21, 2013, issued by the Center for Biologics Evaluation and Research, covering biologics.
- Company
- Biomat USA Inc.
- Inspection Date
- February 21, 2013
- Product Type
- Biologics
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ID · e784e26f-4fa4-4cd7-818f-534e3f610de3
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 820529
- FDA center
- Biologics
- Project area
- Blood and Blood Products
FDA Citations
5- 21 CFR 606.100(c)Record review prior to release
- 21 CFR 630.40(b)(1)Deferred or not eligible
- 21 CFR 606.100(c)Thorough investigations
- 21 CFR 606.40(c)Provide adequate toilet facilities
- 21 CFR 606.171Biological product deviation report
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Other FDA inspections of Biomat USA Inc.
3| Date | Classification | Office | Project area |
|---|---|---|---|
| November 14, 2024 | NAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
| September 24, 2019 | NAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
| September 9, 2015 | NAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
Other documents for Biomat USA Inc.
- FDA Inspection 1254722 - 2024-11-14
- FDA Inspection 1106925 - 2019-09-24
- FDA Inspection 941867 - 2015-09-09
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