Company
United StatesBiomat USA, Inc., Indianapolis, IN – FDA Inspections
Inspection records and compliance data for Biomat USA, Inc. in Indianapolis, Indiana. 5 FDA inspections on record, last inspected August 30, 2019.
Company Profile
This profile covers Biomat USA, Inc. based in Indianapolis, Indiana, United States.
FDA Inspection History
- FDA inspections
- 5
- OAI
- 0
- VAI
- 2
- NAI
- 3
- Form 483s
- 0
- Warning letters
- 0
First inspected January 27, 2010. Last inspected August 30, 2019.
Most cited issue areas
- Establish, maintain and follow manufacturing SOPs1 inspection
- Notification1 inspection
- Prevention of contamination1 inspection
FDA inspections (5)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| August 30, 2019 | NAI | Biologics · Blood and Blood Products | 1105254 |
| September 29, 2015 | NAI | Biologics · Blood and Blood Products | 946028 |
| October 2, 2012 | VAI | Biologics · Blood and Blood Products | 801691 |
| September 15, 2010 | NAI | Biologics · Blood and Blood Products | 680606 |
| January 27, 2010 | VAI | Biologics · Blood and Blood Products | 640977 |
FDA documents
No Form 483s, Warning Letters or EIRs on record.
Related Companies (10)
Companies with similar regulatory profiles, compliance history, and operations.
Company Information
Name
Biomat USA, Inc.
FEI Number
3003733819
Address
3620 N Post Rd, Indianapolis, Indiana 46226, United States
Country
United States
ID: e399bceb-0388-4c06-a0a0-093bdf718211