Chemische Fabrik Berg GmbH

FDA 483 - Chemische Fabrik Berg GmbH

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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.

Company: Chemische Fabrik Berg GmbH
Product Type: Drugs
Office: Division of Clinical Evidence and Analysis 1 (Clinical Policy and Quality)
Person: Doan T. Nguyen (Microbiologist )

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