Company
United StatesBiomat USA, Inc., South Bend, IN – FDA Inspections
Inspection records and compliance data for Biomat USA, Inc. in South Bend, Indiana. 4 FDA inspections on record, last inspected October 21, 2019.
Company Profile
This profile covers Biomat USA, Inc. based in South Bend, Indiana, United States.
FDA Inspection History
- FDA inspections
- 4
- OAI
- 0
- VAI
- 1
- NAI
- 3
- Form 483s
- 0
- Warning letters
- 0
First inspected March 27, 2009. Last inspected October 21, 2019.
Most cited issue areas
- Donor eligibility1 inspection
- Establish, maintain and follow manufacturing SOPs1 inspection
FDA inspections (4)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| October 21, 2019 | NAI | Biologics · Blood and Blood Products | 1108083 |
| September 29, 2017 | NAI | Biologics · Blood and Blood Products | 1028805 |
| March 9, 2012 | NAI | Biologics · Blood and Blood Products | 771978 |
| March 27, 2009 | VAI | Biologics · Blood and Blood Products | 572502 |
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
1831100
Address
1901 W Western Ave, South Bend, Indiana 46619, United States
Country
United States
ID: 2f79d685-1f13-4bed-8c37-f7b014075e76