483
KDC/ONE Development Corporation, Inc.FDA 483 - KDC/ONE Development Corporation, Inc. - January 27, 2023
Record Details
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.
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ID · 88131bf2-1502-4b0e-8c39-a0ca93d71ae9