Company
United StatesBiomat USA, Inc., Indianapolis, IN – FDA Inspections
Inspection records and compliance data for Biomat USA, Inc. in Indianapolis, Indiana. 3 FDA inspections on record, last inspected September 20, 2018.
Company Profile
This profile covers Biomat USA, Inc. based in Indianapolis, Indiana, United States.
FDA Inspection History
- FDA inspections
- 3
- OAI
- 0
- VAI
- 1
- NAI
- 2
- Form 483s
- 0
- Warning letters
- 0
First inspected January 15, 2010. Last inspected September 20, 2018.
Most cited issue areas
- Biological product deviation report1 inspection
- Establish, maintain and follow manufacturing SOPs1 inspection
- Thorough investigations1 inspection
FDA inspections (3)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| September 20, 2018 | NAI | Biologics · Blood and Blood Products | 1067687 |
| February 2, 2012 | NAI | Biologics · Blood and Blood Products | 770062 |
| January 15, 2010 | VAI | Biologics · Blood and Blood Products | 638921 |
FDA documents
No Form 483s, Warning Letters or EIRs on record.
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Company Information
Name
Biomat USA, Inc.
FEI Number
3006213838
Address
6340 Gateway Dr, Indianapolis, Indiana 46254, United States
Country
United States
ID: 3dd483d8-6679-47b8-8210-1572dcbb55e4