Chartwell Pharmaceuticals LLC – FDA 483, May 31, 2024
Chartwell Pharmaceuticals LLC in Congers, NY, was cited with five observations during an FDA inspection, primarily concerning significant deficiencies within its quality control unit. The firm failed to adhere to established procedures for change control, record review, and log maintenance, indicating a systemic breakdown in quality oversight. Additional issues included inadequate equipment design and qualification, a failure to record deviations from production and process control procedures, and insufficient laboratory controls for sampling drug products.
ID · ea844b40-9502-4e06-82fc-1db726e9b1be
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