FDA Inspection
Biomat USA, Inc.Biomat USA, Inc. – FDA Inspection, Mar 27, 2009
Record Details
This FDA Inspection record concerns Biomat USA, Inc., with an inspection on March 27, 2009, issued by the Center for Biologics Evaluation and Research, covering biologics.
- Company
- Biomat USA, Inc.
- Inspection Date
- March 27, 2009
- Product Type
- Biologics
View Company Profile
ID · cb244d3e-a82b-4b21-8d3f-10dab38b4401
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 572502
- FDA center
- Biologics
- Project area
- Blood and Blood Products
FDA Citations
2- 21 CFR 640.31Donor eligibility
- 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.
3| Date | Classification | Office | Project area |
|---|---|---|---|
| October 21, 2019 | NAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
| September 29, 2017 | NAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
| March 9, 2012 | NAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
Other documents for Biomat USA, Inc.
- FDA Inspection 1108083 - 2019-10-21
- FDA Inspection 1028805 - 2017-09-29
- FDA Inspection 771978 - 2012-03-09
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.