FDA Inspection
Biomat USA, Inc.Biomat USA, Inc. – FDA Inspection, Nov 1, 2010
Record Details
This FDA Inspection record concerns Biomat USA, Inc., with an inspection on November 1, 2010, issued by the Center for Biologics Evaluation and Research, covering biologics.
- Company
- Biomat USA, Inc.
- Inspection Date
- November 1, 2010
- Product Type
- Biologics
View Company Profile
ID · 07a5a0f7-3bbc-4200-ae55-42095ab47725
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 696650
- FDA center
- Biologics
- Project area
- Blood and Blood Products
FDA Citations
1- 21 CFR 606.100(b)Establish, maintain and follow manufacturing SOPs
Full citation text and observation details available on the Dashboard.
Other FDA inspections of Biomat USA, Inc.
5| Date | Classification | Office | Project area |
|---|---|---|---|
| November 3, 2022 | NAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
| March 13, 2018 | NAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
| September 5, 2014 | NAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
| December 16, 2011 | VAI | 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 1190568 - 2022-11-03
- FDA Inspection 1044832 - 2018-03-13
- FDA Inspection 893917 - 2014-09-05
- FDA Inspection 759129 - 2011-12-16
- FDA Inspection 554942 - 2008-12-12
Document or profile
One record shows the event. A profile shows the pattern.
Buy this document for the source file and details behind this single event.
Choose full profile access to connect related records, sites, people, citations, and enforcement history in one view.