FDA Inspection
Biomat USA IncBiomat USA Inc – FDA Inspection, Jan 15, 2010
Record Details
This FDA Inspection record concerns Biomat USA Inc, with an inspection on January 15, 2010, issued by the Center for Biologics Evaluation and Research, covering biologics.
- Company
- Biomat USA Inc
- Inspection Date
- January 15, 2010
- Product Type
- Biologics
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ID · 0bf4c0fd-985e-4198-9ef3-fe36c42aab87
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 645237
- FDA center
- Biologics
- Project area
- Blood and Blood Products
FDA Citations
2- 21 CFR 606.100(c)Thorough investigations
- 21 CFR 606.100(b)Establish, maintain and follow manufacturing SOPs
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Other FDA inspections of Biomat USA Inc
5| Date | Classification | Office | Project area |
|---|---|---|---|
| October 31, 2024 | NAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
| February 13, 2018 | NAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
| January 29, 2016 | NAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
| July 1, 2014 | NAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
| September 21, 2012 | NAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
Other documents for Biomat USA Inc
- FDA Inspection 1254435 - 2024-10-31
- FDA Inspection 1044390 - 2018-02-13
- FDA Inspection 961907 - 2016-01-29
- FDA Inspection 887076 - 2014-07-01
- FDA Inspection 800204 - 2012-09-21
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