FDA Inspection
Biomat USA, Inc.Biomat USA, Inc. – FDA Inspection, Oct 2, 2012
Record Details
This FDA Inspection record concerns Biomat USA, Inc., with an inspection on October 2, 2012, issued by the Center for Biologics Evaluation and Research, covering biologics.
- Company
- Biomat USA, Inc.
- Inspection Date
- October 2, 2012
- Product Type
- Biologics
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ID · 0d8fb191-d241-4abb-84d7-5e56e3aeafdb
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 801691
- FDA center
- Biologics
- Project area
- Blood and Blood Products
FDA Citations
4- 21 CFR 630.40(a)Notification
- 21 CFR 606.20(b)Qualifications of responsible personnel
- 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 |
|---|---|---|---|
| August 30, 2019 | NAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
| September 29, 2015 | NAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
| September 15, 2010 | NAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
| January 27, 2010 | VAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
Other documents for Biomat USA, Inc.
- FDA Inspection 1105254 - 2019-08-30
- FDA Inspection 946028 - 2015-09-29
- FDA Inspection 680606 - 2010-09-15
- FDA Inspection 640977 - 2010-01-27
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