FDA 483 - Chemische Fabrik Berg GmbH

An inspection of Chemische Fabrik Berg GmbH in Bitterfeld-Wolfen, Germany, revealed significant deficiencies in data integrity and quality control. The firm failed to maintain appropriate controls over computer systems, allowing manual data manipulation and unauthorized access, and did not adequately review electronic data. Additionally, the company lacked proper written procedures, had inadequate equipment cleaning protocols, and failed to thoroughly investigate deviations and ensure adequate employee training.