FDA Inspection
Biomat USA, Inc.Biomat USA, Inc. – FDA Inspection, Mar 21, 2012
Record Details
This FDA Inspection record concerns Biomat USA, Inc., with an inspection on March 21, 2012, issued by the Center for Biologics Evaluation and Research, covering biologics.
- Company
- Biomat USA, Inc.
- Inspection Date
- March 21, 2012
- Product Type
- Biologics
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ID · 79ec963d-d1ea-40bd-a90b-8fe8f26b3241
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 773242
- FDA center
- Biologics
- Project area
- Blood and Blood Products
FDA Citations
2- 21 CFR 606.160(a)(1)Concurrent documentation
- 21 CFR 606.100(b)Establish, maintain and follow manufacturing SOPs
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Other FDA inspections of Biomat USA, Inc.
3| Date | Classification | Office | Project area |
|---|---|---|---|
| July 16, 2018 | NAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
| March 26, 2015 | NAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
| August 20, 2014 | NAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
Other documents for Biomat USA, Inc.
- FDA Inspection 1061151 - 2018-07-16
- FDA Inspection 920516 - 2015-03-26
- FDA Inspection 893666 - 2014-08-20
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