FDA 483 - G. C. Hanford Manufacturing Co - March 20, 2025
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G. C. Hanford Manufacturing Co. in Syracuse, NY, a drug product manufacturer, was inspected and cited for multiple significant deficiencies. The inspection revealed failures in quality control procedures for sterile media fills, poor facility maintenance including unsanitary conditions and damaged aseptic processing areas, and inadequately maintained equipment. Additionally, the firm lacked proper requalification of temperature-controlling units and had deficient environmental and personnel monitoring procedures in aseptic areas.
ID · 7d3e53b0-04f9-4a3f-a3fc-2fab46926a9d