FDA Inspection
Biomat USA, IncBiomat USA, Inc – FDA Inspection, Feb 11, 2020
Record Details
This FDA Inspection record concerns Biomat USA, Inc, with an inspection on February 11, 2020, issued by the Center for Biologics Evaluation and Research, covering biologics.
- Company
- Biomat USA, Inc
- Inspection Date
- February 11, 2020
- Product Type
- Biologics
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ID · 1ee54935-b374-4dbd-9c75-ca97263daa21
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1118061
- FDA center
- Biologics
- Project area
- Blood and Blood Products
FDA Citations
2- 21 CFR 606.40(a)(1)Provide space for examination
- 21 CFR 640.64(e)Prevention of contamination
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Other FDA inspections of Biomat USA, Inc
6| Date | Classification | Office | Project area |
|---|---|---|---|
| October 13, 2023 | NAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
| July 20, 2017 | NAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
| August 18, 2015 | NAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
| September 25, 2013 | NAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
| May 5, 2011 | NAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
Other documents for Biomat USA, Inc
- FDA Inspection 1220609 - 2023-10-13
- FDA Inspection 1018966 - 2017-07-20
- FDA Inspection 938657 - 2015-08-18
- FDA Inspection 849952 - 2013-09-25
- FDA Inspection 721933 - 2011-05-05
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