LANXESS CorporationSeptember 9, 2024

FDA 483 - LANXESS Corporation - September 09, 2024

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Record Details

LANXESS Corporation in Kalama, WA, was inspected from September 9-12, 2024, revealing a significant issue with equipment maintenance. A reactor tank used for Sodium Benzoate production has been leaking product since 2021, with no documented deviation or investigation into the recurring problem. This indicates a serious lapse in maintaining equipment in a good state of repair.

Company: LANXESS Corporation
Inspection Date: September 9, 2024
Product Type: Drugs
Office: Division of Human and Animal Food Operations - West VI
People: Nathan E. Hellman
Kham Phommachanh (Investigator)

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ID · e85d9fd7-963d-49be-92cd-f164cf2e9903