FDA Inspection
Biomat USA IncBiomat USA Inc – FDA Inspection, May 28, 2010
Record Details
This FDA Inspection record concerns Biomat USA Inc, with an inspection on May 28, 2010, issued by the Center for Biologics Evaluation and Research, covering biologics.
- Company
- Biomat USA Inc
- Inspection Date
- May 28, 2010
- Product Type
- Biologics
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ID · 8ad612bf-c070-4604-9f0b-489ea4a85092
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 664475
- FDA center
- Biologics
- Project area
- Blood and Blood Products
FDA Citations
2- 21 CFR 640.64(e)Prevention of contamination
- 21 CFR 606.100(b)Establish, maintain and follow manufacturing SOPs
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Other FDA inspections of Biomat USA Inc
4| Date | Classification | Office | Project area |
|---|---|---|---|
| January 24, 2020 | NAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
| August 31, 2017 | VAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
| September 11, 2015 | NAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
| September 21, 2012 | VAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
Other documents for Biomat USA Inc
- FDA Inspection 1117568 - 2020-01-24
- FDA Inspection 1023704 - 2017-08-31
- FDA Inspection 941980 - 2015-09-11
- FDA Inspection 800092 - 2012-09-21
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