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•United States

ASEPTIKITS, LLC, North Salt Lake, UT – FDA Inspections

Inspection records and compliance data for ASEPTIKITS, LLC in North Salt Lake, UT. 1 FDA inspection on record, 1 Form 483, 1 warning letter, last inspected December 03, 2025.

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Company Profile

This profile covers ASEPTIKITS, LLC based in North Salt Lake, UT, United States.

FDA Inspection History

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

Inspected December 3, 2025.

Most cited issue areas

  • Design control - no procedures1 inspection
  • Devices subject to device identification GUDID data submission requirements.1 inspection
  • DMR - not or inadequately maintained1 inspection

FDA inspections (1)

DateResultFDA center(s)Insp. #
December 3, 2025Not classifiedMedical Devices & Rad Health · Compliance: Medical Devices1288994
FDA documents

Form 483s (1)

  • Form 483s · December 3, 2025

Warning Letters (1)

  • Warning Letters · December 3, 2025
People (3)
Monica L. Gutierrez
Person
James R. Montero
Person
Cesar A. Perez
Person
Related Companies (10)

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Boston Scientific Corporation
Comar Inc.
Soulaire Corporation
Vision Care Holdings, Inc dba The LASIK Vision Institute
Amcor Flexibles, LLC.
USA Medical, LLC
Company Information

Name

ASEPTIKITS, LLC

FEI Number

3015422213

Address

101 N 700 W, North Salt Lake, UT 84054-2735, United States

Country

United States

ID: 3d3b1df5-4125-46b6-bacb-d99ea76fcedd

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