Company
United StatesBiomat USA, Inc., Farmington Hills, MI – FDA Inspections
Inspection records and compliance data for Biomat USA, Inc. in Farmington Hills, Michigan. 5 FDA inspections on record, last inspected September 13, 2018.
Company Profile
This profile covers Biomat USA, Inc. based in Farmington Hills, Michigan, United States.
FDA Inspection History
- FDA inspections
- 5
- OAI
- 0
- VAI
- 2
- NAI
- 3
- Form 483s
- 0
- Warning letters
- 0
First inspected December 12, 2008. Last inspected September 13, 2018.
Most cited issue areas
- Establish, maintain and follow manufacturing SOPs2 inspections
- Adverse reaction - Maintenance of Reports1 inspection
- Schedules and procedures for equipment & calibration1 inspection
FDA inspections (5)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| September 13, 2018 | NAI | Biologics · Blood and Blood Products | 1068977 |
| March 14, 2014 | NAI | Biologics · Blood and Blood Products | 869867 |
| September 21, 2012 | NAI | Biologics · Blood and Blood Products | 800223 |
| November 10, 2010 | VAI | Biologics · Blood and Blood Products | 697740 |
| December 12, 2008 | VAI | Biologics · Blood and Blood Products | 552512 |
FDA documents
No Form 483s, Warning Letters or EIRs on record.
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Companies with similar regulatory profiles, compliance history, and operations.
Company Information
Name
Biomat USA, Inc.
FEI Number
1572453
Address
28400 Grand River Ave, Farmington Hills, Michigan 48336, United States
Country
United States
ID: 59b65d27-be46-4ab1-b15e-6f27b3d7b0cf