FDA 483 - KDC/ONE Development Corporation, Inc. - January 27, 2023

KDC/ONE Development Corporation, Inc. in Knowlton, a non-sterile contract drug manufacturer, was cited for deficiencies in laboratory record-keeping and production control procedures. Observations included a lack of proper documentation for test performance and unrecorded/unjustified deviations from written procedures during batch production. These issues indicate concerns with data integrity and adherence to established manufacturing processes.