FDA 483 - Wasserburger Arzneimittelwerk GmbH

An FDA inspection of Wasserburg Arzneimittelwek GmbH (Recipharm) in Wasserburg a. Inn, Germany, a drug product manufacturer, identified significant deficiencies in the adherence to and adequacy of Standard Operating Procedures. The observations highlight issues across environmental monitoring, sanitization, material handling, labeling, and personnel segregation, indicating a systemic failure in maintaining controlled manufacturing operations. These findings suggest a moderate severity of non-compliance with established operational guidelines.