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Biomat USA, Inc, Arlington, TX – FDA Inspections

Inspection records and compliance data for Biomat USA, Inc in Arlington, Texas. 6 FDA inspections on record, 1 Form 483, last inspected July 23, 2021.

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Company Profile

This profile covers Biomat USA, Inc based in Arlington, Texas, United States.

FDA Inspection History

FDA inspections
6
OAI
0
VAI
1
NAI
5
Form 483s
1
Warning letters
0

First inspected March 19, 2010. Last inspected July 23, 2021.

Most cited issue areas

  • Biological product deviation report1 inspection
  • Equipment1 inspection
  • Maintenance - tracing1 inspection

FDA inspections (6)

DateResultFDA center(s)Insp. #
July 23, 2021NAIBiologics · Blood and Blood Products1149030
December 3, 2018VAIBiologics · Blood and Blood Products1073344
September 14, 2016NAIBiologics · Blood and Blood Products984570
August 21, 2014NAIBiologics · Blood and Blood Products892304
June 6, 2012NAIBiologics · Blood and Blood Products783979
March 19, 2010NAIBiologics · Blood and Blood Products654445
FDA documents

No Form 483s, Warning Letters or EIRs on record.

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Christus Health Ark-La-Tex, Christus St. Michael HealthSystem
Marion C Lanteri, PhD
Qualtex Laboratories
South Texas Blood and Tissue Center Boerne Donor Room
CSL Plasma Inc.
Kelly Orthopaedic Sales, LP
Community Blood Center DBA Community Tissue Services
Company Information

Name

Biomat USA, Inc

FEI Number

3004036082

Address

1519 S Cooper St, Arlington, Texas 76010, United States

Country

United States

ID: e79225e2-3a22-4b84-8982-ec052660207d

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