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•United States

Certified Laboratories LLC, Carrollton, TX – FDA Inspections

Inspection records and compliance data for Certified Laboratories LLC in Carrollton, Texas. 5 FDA inspections on record (1 OAI), 1 Form 483, last inspected January 31, 2025.

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Company Profile

This profile covers Certified Laboratories LLC based in Carrollton, Texas, United States.

FDA Inspection History

FDA inspections
5
OAI
1
VAI
1
NAI
3
Form 483s
1
Warning letters
0

First inspected February 2, 2010. Last inspected January 31, 2025.

Most cited issue areas

  • Complete Test Data2 inspections
  • Buildings not maintained in good state of repair1 inspection
  • Procedure Deviations Recorded and Justified1 inspection

FDA inspections (5)

DateResultFDA center(s)Insp. #
January 31, 2025VAIHuman Drugs · Drug Quality Assurance1261056
May 20, 2022OAIHuman Drugs · Drug Quality Assurance1169951
November 29, 2016NAIHuman Drugs · Drug Quality Assurance994050
January 27, 2011NAIHuman Drugs · Drug Quality Assurance707191
February 2, 2010NAIHuman Drugs · Drug Quality Assurance648650
FDA documents

Form 483s (2)

  • Form 483s · January 31, 2025
  • Form 483s · May 20, 2022
People (3)
Patty P. Kaewussdangkul
Person
Shanna N. Purdy
Person
Kevin T. Nguyen
Person
Related Companies (10)

Companies with similar regulatory profiles, compliance history, and operations.

Laboratory Service Inc.
ACTA Laboratories, Inc.
Supernus Pharmaceuticals, Inc.
Charles River Laboratories, Inc.
LabChemS Corp.
Davion Inc
Microbiological Consultants, Inc.
Patheon API Manufacturing Inc
ARL Biopharma, Inc.
Vertice Pharma Management Corp
Company Information

Name

Certified Laboratories LLC

FEI Number

3003838850

Address

3218 Commander Dr Ste 100, Carrollton, Texas 75006, United States

Country

United States

ID: d411cf88-a1cd-4155-a3b8-e68ead073add

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