Missouri Analytical Laboratories, Inc.September 2, 2022

FDA 483 - Missouri Analytical Laboratories, Inc. - September 02, 2022

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Record Details

Missouri Analytical Laboratories Inc, a control testing laboratory in Saint Louis, MO, was cited for significant deficiencies in equipment maintenance. Specifically, a laminar air flow hood used for microbiological testing of drug products was found in disrepair, exhibiting rust, broken glass, and dust, with no airflow visualization studies performed. These conditions raise concerns about the safety, identity, strength, quality, and purity of drug products tested.

Company: Missouri Analytical Laboratories, Inc.
Inspection Date: September 2, 2022
Product Type: Drugs
Office: Division of Human and Animal Food Operations - West II
People: Michele Perry-Williams (Investigator)
Jacob G. Lutz (Investigator)
Monica E. Murie

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ID · ee29c40a-a073-442e-a050-e9032839dee9