483
Chartwell Pharmaceuticals LLCChartwell Pharmaceuticals LLC – FDA 483, May 24, 2023
Record Details
Chartwell Pharmaceuticals LLC, a drug manufacturer in Congers, NY, was inspected by the FDA and received six observations. The inspection revealed significant deficiencies in stability data, quality control unit procedures, employee training, production hold times, and facility/equipment readiness for new product manufacturing. These issues indicate a broad lack of adherence to good manufacturing practices.
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ID · de95b640-b564-4faf-9ca2-063958f30e33
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