# FDA 483 - LANXESS Corporation - September 09, 2024

Source: https://www.keypedia.com/records/483/lanxess-corporation/e85d9fd7-963d-49be-92cd-f164cf2e9903

> FDA 483 for LANXESS Corporation on September 09, 2024. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: LANXESS Corporation
- Inspection Date: 2024-09-09
- Product Type: drugs
- Office Name: Division of Human and Animal Food Operations - West VI
- Summary: 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.

## Related Documents

- [EIR - 2013-08-02](https://www.keypedia.com/records/eir/lanxess-corporation/e5e1aaf1-ed4e-44c7-8fa1-6121b4738582)
- [483 - 2016-01-15](https://www.keypedia.com/records/483/lanxess-corporation/b3ec1f98-f973-461c-8de4-90ab45ad85b6)

## Related Officers

- [Nathan E. Hellman](https://www.keypedia.com/people/nathan-e-hellman/88dc6c17-72bf-4c2c-a952-a4ebcd742142)
- [Investigator](https://www.keypedia.com/people/kham-phommachanh/cc7e728e-d2a1-469d-be3a-4f5fdd43b2dc)

Company: https://www.keypedia.com/companies/lanxess-corporation/d4d93912-8e03-47f0-87e8-1aac96f0a44d

Office: https://www.keypedia.com/offices/division-of-human-and-animal-food-operations-west-vi/6e5a2a08-f464-4979-a759-7b0383370822