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•United States

IVIMEA LLC, Monroe Township, NJ – FDA Inspections

Inspection records and compliance data for IVIMEA LLC in Monroe Township, New Jersey. 2 FDA inspections on record, 1 Form 483, last inspected March 31, 2026.

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Company Profile

This profile covers IVIMEA LLC based in Monroe Township, New Jersey, United States.

FDA Inspection History

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

First inspected June 24, 2019. Last inspected March 31, 2026.

Most cited issue areas

  • Aperture label1 inspection
  • Certification not based on adequate test/testing program1 inspection
  • Class IV "Danger" label1 inspection

FDA inspections (2)

DateResultFDA center(s)Insp. #
March 31, 2026Not classifiedMedical Devices & Rad Health · Compliance: Medical Devices1311588
June 24, 2019NAIMedical Devices & Rad Health · Radiation Control and Health Safety Act1109734
FDA documents

Form 483s (1)

  • Form 483s · March 31, 2026
People (1)
Frank J. Marciniak
Person
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Company Information

Name

IVIMEA LLC

FEI Number

3013986441

Address

1095 Cranbury South River Rd Ste 14, Monroe Township, New Jersey 08831, United States

Country

United States

ID: 8dc19887-262c-4480-9d0f-6dbcbdab53a7

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