Company
United StatesBiomat USA, Inc, Pittsburgh, PA – FDA Inspections
Inspection records and compliance data for Biomat USA, Inc in Pittsburgh, Pennsylvania. 6 FDA inspections on record, 1 Form 483, last inspected October 25, 2024.
Company Profile
This profile covers Biomat USA, Inc based in Pittsburgh, Pennsylvania, United States.
FDA Inspection History
- FDA inspections
- 6
- OAI
- 0
- VAI
- 3
- NAI
- 3
- Form 483s
- 1
- Warning letters
- 0
First inspected February 19, 2009. Last inspected October 25, 2024.
Most cited issue areas
- Establish, maintain and follow manufacturing SOPs2 inspections
- Procedures not in writing, fully followed2 inspections
- Thorough investigations2 inspections
FDA inspections (6)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| October 25, 2024 | NAI | Biologics · Blood and Blood Products | 1253778 |
| February 15, 2017 | VAI | Biologics · Blood and Blood Products | 1005674 |
| February 4, 2015 | NAI | Biologics · Blood and Blood Products | 912526 |
| December 7, 2012 | VAI | Biologics · Blood and Blood Products | 808445 |
| January 12, 2011 | NAI | Biologics · Blood and Blood Products | 706602 |
| February 19, 2009 | VAI | Biologics · Blood and Blood Products | 562135 |
FDA documents
No Form 483s, Warning Letters or EIRs on record.
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Company Information
Name
Biomat USA, Inc
FEI Number
2572454
Address
1330 Western Ave, Pittsburgh, Pennsylvania 15233, United States
Country
United States
ID: b6273141-77b1-4ec0-948b-501e4d7ef2b2