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StemGenex Biologic Laboratories, LLC, San Diego, CA – FDA Inspections

Inspection records and compliance data for StemGenex Biologic Laboratories, LLC in San Diego, California. 1 FDA inspection on record (1 OAI), 1 Form 483, last inspected January 26, 2018.

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Company Profile

This profile covers StemGenex Biologic Laboratories, LLC based in San Diego, California, United States.

FDA Inspection History

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

Inspected January 26, 2018.

Most cited issue areas

  • Absence of Written Procedures1 inspection
  • Cleaning System1 inspection
  • Complaint Handling Procedure1 inspection

FDA inspections (1)

DateResultFDA center(s)Insp. #
January 26, 2018OAIBiologics · Human Cellular, Tissue, and Gene Therapies1038758
FDA documents

Form 483s (1)

  • Form 483s · January 26, 2018
People (2)
Yvonne C. Wilkes
Person
Colleen Aspinwall
Person
Related Companies (10)

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Robert D. Ferrera, MD
Iovance Biotherapeutics, Inc.
Central California Blood Center/ Clovis Donor Center
Shireen V. Guide, M.D.
Atara Biotherapeutics, Inc.
Company Information

Name

StemGenex Biologic Laboratories, LLC

FEI Number

3013138338

Address

11515 El Camino Real Ste 100, San Diego, California 92130, United States

Country

United States

ID: 047276e3-17d7-4742-9dae-2e1fc4b49724

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