# FDA 483 - Venator Germany GmbH - September 22, 2017

Source: https://www.keypedia.com/records/483/venator-germany-gmbh/d36d8993-40bd-439b-8ba9-6c0705d15bc0

> FDA 483 for Venator Germany GmbH on September 22, 2017. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Venator Germany GmbH
- Inspection Date: 2017-09-22
- Product Type: drugs
- Office Name: International Compliance Team
- Summary: The FDA inspected Venator, an API manufacturer in Duisburg, Germany, and issued a Form 483 with seven observations. The findings highlight significant deficiencies across laboratory controls, production systems, facilities, materials, and the quality unit. Issues include failures in stability programs, sampling plan rationale, batch record management, cleaning procedures, raw material specifications, and overall quality unit responsibilities.

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Company: https://www.keypedia.com/companies/venator-germany-gmbh/fa92309d-b1be-4827-bb4f-b06f6a8df55a

Office: https://www.keypedia.com/offices/international-compliance-team/f0ce0d89-bf39-46c6-8c42-28138d161321