SpecGx, LLCSeptember 17, 2021

FDA 483 - SpecGx, LLC - September 17, 2021

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Record Details

SpecGx, LLC in Webster Groves, MO, was cited for significant deficiencies across its drug product manufacturing operations. The inspection revealed issues with contamination control in weighing rooms, inadequate testing of water system components, and widespread failures in quality control procedures. Additionally, the facility exhibited poor equipment maintenance and unsanitary building conditions, including evidence of pest activity.

Company: SpecGx, LLC
Inspection Date: September 17, 2021
Product Type: Drugs
Office: Division of Human and Animal Food Operations - West II
People: Joseph A. Piechocki
Arsen Karapetyan

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ID · bc45e382-5375-47a8-a820-74d64cf82527