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•United States

SURGENEX LLC, Scottsdale, AZ – FDA Inspections

Inspection records and compliance data for SURGENEX LLC in Scottsdale, Arizona. 2 FDA inspections on record (1 OAI), 1 Form 483, 1 warning letter, last inspected March 29, 2023.

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Company Profile

This profile covers SURGENEX LLC based in Scottsdale, Arizona, United States.

FDA Inspection History

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

First inspected April 16, 2021. Last inspected March 29, 2023.

Most cited issue areas

  • In-process HCT/Ps-control1 inspection

FDA inspections (2)

DateResultFDA center(s)Insp. #
March 29, 2023NAIBiologics · Blood and Blood Products1201113
April 16, 2021OAIBiologics · Human Cellular, Tissue, and Gene Therapies1140292
FDA documents

Form 483s (2)

  • Form 483s · March 29, 2023
  • Form 483s · April 16, 2021

Warning Letters (1)

  • Warning Letters · April 16, 2021
People (5)
Lewis K. Antwi
Person
Abby L. Mozeke-Baker
Person
Karlton T. Watson
Person
Kaarin M. Slotte
Person
Garrad R. Poole
Person
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Company Information

Name

SURGENEX LLC

FEI Number

3011692533

Address

15444 N 76th St Ste 110, Scottsdale, Arizona 85260, United States

Country

United States

ID: 7577df14-aa69-4670-89bf-a4e3f4f8d691

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