FDA 483 - Haupt Pharma Muenster GmbH - July 06, 2018

An FDA inspection of Haupt Pharma Muenster GmbH in Munster, Germany, revealed significant deficiencies in their quality control unit, including inadequate failure investigations and stability testing reviews. The firm also lacked appropriate controls over electronic data systems, compromising data integrity, and failed to establish written procedures for critical production and process controls, particularly for contract analytical testing. These observations indicate a need for comprehensive improvements in their quality management system.