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•United States

Mirodx, Dallas, TX – FDA Inspections

Inspection records and compliance data for Mirodx in Dallas, Texas. 1 FDA inspection on record, 1 Form 483, last inspected September 26, 2025.

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Company Profile

This profile covers Mirodx based in Dallas, Texas, United States.

FDA Inspection History

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

Inspected September 26, 2025.

Most cited issue areas

  • Acceptable supplier records, inadequate records1 inspection
  • Design Validation - Risk analysis not performed/inadequate1 inspection
  • Quality audits - auditor independence1 inspection

FDA inspections (1)

DateResultFDA center(s)Insp. #
September 26, 2025NAIMedical Devices & Rad Health · Postmarket Assurance: Medical Devices1283810
FDA documents

Form 483s (1)

  • Form 483s · September 26, 2025
People (2)
Katherine M. Thames
Person
Katlin N. Stubbs
Person
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Bioteque America, Inc
KENERIC HEALTHCARE
VASTMED LLC
Company Information

Name

Mirodx

FEI Number

3023463102

Address

7920 Belt Line Rd Ste 210, Dallas, Texas 75254, United States

Country

United States

ID: 32dd43f8-f43f-4cc4-9d4e-6df9bf2dfce1

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