Company
United StatesBiomat USA Inc, Gary, IN – FDA Inspections
Inspection records and compliance data for Biomat USA Inc in Gary, Indiana. 4 FDA inspections on record, 1 Form 483, last inspected October 02, 2017.
Company Profile
This profile covers Biomat USA Inc based in Gary, Indiana, United States.
FDA Inspection History
- FDA inspections
- 4
- OAI
- 0
- VAI
- 4
- NAI
- 0
- Form 483s
- 1
- Warning letters
- 0
First inspected July 17, 2009. Last inspected October 2, 2017.
Most cited issue areas
- Establish, maintain and follow manufacturing SOPs2 inspections
- Donor deferral record - each location1 inspection
- When to report1 inspection
FDA inspections (4)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| October 2, 2017 | VAI | Biologics · Blood and Blood Products | 1028241 |
| January 14, 2013 | VAI | Biologics · Blood and Blood Products | 815098 |
| April 28, 2011 | VAI | Biologics · Blood and Blood Products | 724917 |
| July 17, 2009 | VAI | Biologics · Blood and Blood Products | 606686 |
FDA documents
No Form 483s, Warning Letters or EIRs on record.
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Company Information
Name
Biomat USA Inc
FEI Number
1876560
Address
1504 Broadway, Gary, Indiana 46407, United States
Country
United States
ID: d0105a05-f954-4265-9196-ee950cbcb704