# FDA 483 - Chemische Fabrik Berg GmbH - Unknown Date

Source: https://www.keypedia.com/records/483/chemische-fabrik-berg-gmbh/cb25088d-95a0-4fac-9864-bcbc265db47a

> FDA 483 for Chemische Fabrik Berg GmbH on Unknown Date. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Chemische Fabrik Berg GmbH
- Product Type: drugs
- Office Name: Division of Clinical Evidence and Analysis 1 (Clinical Policy and Quality)
- Summary: 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.

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Company: https://www.keypedia.com/companies/chemische-fabrik-berg-gmbh/0cde20ec-4ddc-42b5-bbdb-4c85d0e404b0

Office: https://www.keypedia.com/offices/division-of-clinical-evidence-and-analysis-1-clinical-policy-and-quality/5f95da17-30bb-423f-b892-5ea041823fbd