FDA Inspection
Biomat USA, Inc.Biomat USA, Inc. – FDA Inspection, Nov 10, 2010
Record Details
This FDA Inspection record concerns Biomat USA, Inc., with an inspection on November 10, 2010, issued by the Center for Biologics Evaluation and Research, covering biologics.
- Company
- Biomat USA, Inc.
- Inspection Date
- November 10, 2010
- Product Type
- Biologics
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ID · 1ff520c9-1b69-4c9a-82a8-edce02799a7e
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 697740
- FDA center
- Biologics
- Project area
- Blood and Blood Products
FDA Citations
3- 21 CFR 606.170(a)Adverse reaction - Maintenance of Reports
- 21 CFR 606.100(b)(15)Schedules and procedures for equipment & calibration
- 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 13, 2018 | NAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
| March 14, 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 |
| December 12, 2008 | VAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
Other documents for Biomat USA, Inc.
- FDA Inspection 1068977 - 2018-09-13
- FDA Inspection 869867 - 2014-03-14
- FDA Inspection 800223 - 2012-09-21
- FDA Inspection 552512 - 2008-12-12
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