Company
United StatesBiomat USA Inc, Waukegan, IL – FDA Inspections
Inspection records and compliance data for Biomat USA Inc in Waukegan, Illinois. 5 FDA inspections on record, last inspected March 28, 2019.
Company Profile
This profile covers Biomat USA Inc based in Waukegan, Illinois, United States.
FDA Inspection History
- FDA inspections
- 5
- OAI
- 0
- VAI
- 1
- NAI
- 4
- Form 483s
- 0
- Warning letters
- 0
First inspected April 21, 2011. Last inspected March 28, 2019.
Most cited issue areas
- Establish, maintain and follow manufacturing SOPs1 inspection
- Following manufacturer"s instructions1 inspection
- Physician review of results1 inspection
FDA inspections (5)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| March 28, 2019 | NAI | Biologics · Blood and Blood Products | 1089646 |
| March 19, 2018 | NAI | Biologics · Blood and Blood Products | 1052043 |
| July 19, 2016 | NAI | Biologics · Blood and Blood Products | 985194 |
| September 28, 2014 | NAI | Biologics · Blood and Blood Products | 898357 |
| April 21, 2011 | VAI | Biologics · Blood and Blood Products | 720538 |
FDA documents
No Form 483s, Warning Letters or EIRs on record.
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Company Information
Name
Biomat USA Inc
FEI Number
3003854877
Address
2609 Grand Ave, Waukegan, Illinois 60085, United States
Country
United States
ID: 66144318-3044-4c19-845a-8f670b2ba31a