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CellSure, L3C, Salt Lake City, UT – FDA Inspections

Inspection records and compliance data for CellSure, L3C in Salt Lake City, Utah. 2 FDA inspections on record, 1 Form 483, last inspected December 08, 2023.

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Company Profile

This profile covers CellSure, L3C based in Salt Lake City, Utah, United States.

FDA Inspection History

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

First inspected August 2, 2021. Last inspected December 8, 2023.

Most cited issue areas

  • Lack of written stability program2 inspections
  • Risk factors, clinical evidence2 inspections
  • Written warehousing procedures established/followed2 inspections

FDA inspections (2)

DateResultFDA center(s)Insp. #
December 8, 2023VAIBiologics · Human Cellular, Tissue, and Gene Therapies1224419
August 2, 2021VAIBiologics · Human Cellular, Tissue, and Gene Therapies1147632
FDA documents

Form 483s (2)

  • Form 483s · December 8, 2023
  • Form 483s · August 2, 2021
People (3)
Emily B. Camire
Person
Scott T. Ballard
Person
Creighton T. Tuzon
Person
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Company Information

Name

CellSure, L3C

FEI Number

3014621414

Address

615 S Arapeen Dr Ste 300, Salt Lake City, Utah 84108, United States

Country

United States

ID: 6133765e-3818-4bbf-8871-962046a40e8c

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