483
Dendreon Pharmaceuticals LLCFDA 483 - Dendreon Pharmaceuticals LLC - October 22, 2018
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Record Details
The FDA inspected Dendreon Pharmaceuticals Inc. in Union City, GA, and identified significant deficiencies in their quality assurance processes. Observations included failures to review all pertinent records before releasing final products, which led to erroneous potency information and disposition errors. Additionally, the firm lacked proper documentation for corrective actions taken.
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ID · a4c2e9e4-ef11-46c5-89bc-9f9f39b154b3