483
Lyocontract GmbHFDA 483 - Lyocontract GmbH - September 20, 2019
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An FDA inspection of Lyocontract GmbH, a contract drug manufacturer in Ilsenburg (Harz), Germany, revealed significant deficiencies in laboratory controls. Observations included inadequate validation of test methods, insufficient documentation of testing procedures, and incomplete records for laboratory reference standards. These issues indicate a lack of robust quality control in their analytical operations.
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ID · e60440bc-39ae-47d9-99fd-47a918e9bd2f