Company
United StatesBiomat USA, Inc., Flint, MI – FDA Inspections
Inspection records and compliance data for Biomat USA, Inc. in Flint, Michigan. 5 FDA inspections on record, last inspected September 06, 2019.
Company Profile
This profile covers Biomat USA, Inc. based in Flint, Michigan, United States.
FDA Inspection History
- FDA inspections
- 5
- OAI
- 0
- VAI
- 2
- NAI
- 3
- Form 483s
- 0
- Warning letters
- 0
First inspected April 1, 2009. Last inspected September 6, 2019.
Most cited issue areas
- Biological product deviation report1 inspection
- Controlling storage temperatures1 inspection
- Donor criteria1 inspection
FDA inspections (5)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| September 6, 2019 | NAI | Biologics · Blood and Blood Products | 1105504 |
| August 16, 2013 | NAI | Biologics · Blood and Blood Products | 848169 |
| April 12, 2013 | NAI | Biologics · Blood and Blood Products | 832517 |
| September 22, 2011 | VAI | Biologics · Blood and Blood Products | 747581 |
| April 1, 2009 | VAI | Biologics · Blood and Blood Products | 573528 |
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
3005524146
Address
4027 N Jennings Rd, Flint, Michigan 48504, United States
Country
United States
ID: 3b6f66e1-640f-4863-9d62-a11ab82787f7