483
GLPGCP Development (Asia) Pte. Ltd.FDA 483 - GLPGCP Development (Asia) Pte. Ltd. - April 19, 2018
Record Details
An FDA inspection of Humanoptics Ag., a manufacturer in Sankt Augustin, Germany, identified two significant issues. The firm was cited for inadequate validation of processes where results cannot be fully verified by subsequent inspection and test. Additionally, procedures for corrective and preventive action were found to be inadequately established.
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ID · 4fd7e91c-468e-4aed-8198-505eaef4128a