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•United States

Medalliance, LLC, Irvine, CA – FDA Inspections

Inspection records and compliance data for Medalliance, LLC in Irvine, California. 2 FDA inspections on record, 2 Form 483s, last inspected June 18, 2026.

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Company Profile

This profile covers Medalliance, LLC based in Irvine, California, United States.

FDA Inspection History

FDA inspections
2
OAI
0
VAI
1
NAI
0
Unclassified
1
Form 483s
2
Warning letters
0

First inspected February 20, 2026. Last inspected June 18, 2026.

Most cited issue areas

  • Production controls not adequate1 inspection
  • Requirements for contamination control of sterile devices not documented1 inspection
  • Sponsors' general responsibilities1 inspection

FDA inspections (2)

DateResultFDA center(s)Insp. #
June 18, 2026Not classifiedMedical Devices & Rad Health · Project Evaluation: Devices1317486
February 20, 2026VAIMedical Devices & Rad Health · Product Evaluation: Medical Devices1303688
FDA documents

Form 483s (1)

  • Form 483s · June 18, 2026
People (2)
Christopher R. Czajka
Person
Luis P. Torres
Person
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Company Information

Name

Medalliance, LLC

FEI Number

3015190176

Address

Irvine, California 92618, United States

Country

United States

ID: 4fed3b78-f87c-4b2b-942a-c582537c51a0

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