FDA 483 - Venator Germany GmbH - September 22, 2017

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.