483
SterCUBE Surgical Systems LLCSterCUBE Surgical Systems LLC – FDA 483, Mar 17, 2023
Record Details
SteriCube, LLC, a manufacturer of Class II Multiple Tray Sterilization Systems in Gulfport, FL, was inspected by the FDA. The inspection revealed one observation concerning inadequately established procedures for corrective and preventive actions (CAPA). Specifically, the firm's CAPA procedure lacked requirements for standardized analysis of quality data and comprehensive documentation of CAPA activities.
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ID · 58fde35a-3a8e-4578-9140-2f7f35514d90
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