483
Thymoorgan Pharmazie GmbhFDA 483 - Thymoorgan Pharmazie Gmbh - April 25, 2023
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Record Details
Thymoorgan Pharmazie Gmbh, a sterile drug manufacturer in Goslar, Germany, received a Form 483 with three observations. The inspection revealed significant deficiencies in discrepancy investigations, environmental monitoring for aseptic processing, and adherence to and documentation of production procedures. These issues indicate a lack of control over critical manufacturing processes for sterile drug products.
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ID · 91dc3480-59c7-4907-a84a-4c3bfc75a1ae