483
Dendreon Pharmaceuticals LLCDendreon Pharmaceuticals LLC – FDA 483, Oct 29, 2025
Record Details
An FDA inspection of Dendreon Pharmaceuticals LLC in Union City, GA, revealed significant deficiencies in laboratory record-keeping and manufacturing process controls. The firm failed to maintain complete data for invalid test results for its PROVENGE® drug product and continued to use disinfectants despite failed efficacy studies without proper investigation. These issues indicate a lack of robust quality control and data integrity.
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- Atlanta District Office
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ID · 02475899-e839-4b59-9576-e51710d93dae
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