Certified Laboratories LLCMay 20, 2022

FDA 483 - Certified Laboratories LLC - May 20, 2022

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Record Details

Certified Lab Dallas, LLC. dba Microconsult, Inc, a contract testing laboratory in Carrollton, TX, was cited for significant deficiencies across its laboratory and facility systems. Observations included unvalidated in-house test methods, widespread issues with laboratory record integrity and data control, and poor facility maintenance. The findings indicate a lack of robust quality control and adherence to established procedures.

Company: Certified Laboratories LLC
Inspection Date: May 20, 2022
Product Type: Drugs
Office: Division of Human and Animal Food Operations - West III
People: Patty P. Kaewussdangkul (Investigator)
Shanna N. Purdy (Investigator)

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ID · 02ba5b9f-bc47-4815-aef5-fe65931e4825