FDA Slaps Smith & Nephew Inc. With Warning Letter for QC Violations at Massachusetts Site

The FDA sent a warning letter last month to Smith & Nephew (NYSE:SNN), flagging problems found during inspections of the plant in Andover, Mass., where the British healthcare giant makes its Truclear Ultra 4.0 laparoscopic power morcellator.

The April 30 warning letter followed inspections in March at the Andover plant, where the federal safety watchdog found 4 problems with the way Smith & Nephew corrects and validates the manufacturing process for the Truclear Ultra device.

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