Company
United StatesBiomat USA, Inc, Calexico, CA – FDA Inspections
Inspection records and compliance data for Biomat USA, Inc in Calexico, California. 4 FDA inspections on record, last inspected December 13, 2023.
Company Profile
This profile covers Biomat USA, Inc based in Calexico, California, United States.
FDA Inspection History
- FDA inspections
- 4
- OAI
- 0
- VAI
- 2
- NAI
- 2
- Form 483s
- 0
- Warning letters
- 0
First inspected June 21, 2011. Last inspected December 13, 2023.
Most cited issue areas
- Equipment observed, standardized, calibrated1 inspection
- Establish, maintain and follow manufacturing SOPs1 inspection
- Person performing, test results, interpretation1 inspection
FDA inspections (4)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| December 13, 2023 | NAI | Biologics · Blood and Blood Products | 1225670 |
| July 14, 2017 | NAI | Biologics · Blood and Blood Products | 1019092 |
| August 27, 2014 | VAI | Biologics · Blood and Blood Products | 894511 |
| June 21, 2011 | VAI | Biologics · Blood and Blood Products | 731445 |
FDA documents
No Form 483s, Warning Letters or EIRs on record.
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Company Information
Name
Biomat USA, Inc
FEI Number
3006420574
Address
355 E 3rd St, Calexico, California 92231, United States
Country
United States
ID: 24b2fb53-15b0-4107-9db6-1ffaa12bba69