FDA Inspection
Biomat USA, Inc.Biomat USA, Inc. – FDA Inspection, Apr 1, 2009
Record Details
This FDA Inspection record concerns Biomat USA, Inc., with an inspection on April 1, 2009, issued by the Center for Biologics Evaluation and Research, covering biologics.
- Company
- Biomat USA, Inc.
- Inspection Date
- April 1, 2009
- Product Type
- Biologics
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ID · ae8db929-298c-4d0d-872c-bbe256abcd7c
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 573528
- FDA center
- Biologics
- Project area
- Blood and Blood Products
FDA Citations
4- 21 CFR 606.171Biological product deviation report
- 21 CFR 606.20(b)Qualifications of responsible personnel
- 21 CFR 606.100(b)(10)Controlling storage temperatures
- 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 |
|---|---|---|---|
| September 6, 2019 | NAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
| August 16, 2013 | NAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
| April 12, 2013 | NAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
| September 22, 2011 | VAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
Other documents for Biomat USA, Inc.
- FDA Inspection 1105504 - 2019-09-06
- FDA Inspection 848169 - 2013-08-16
- FDA Inspection 832517 - 2013-04-12
- FDA Inspection 747581 - 2011-09-22
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