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.
The FDA published the warning letter on its website May 4. Smith & Nephew put a hold on shipments of the Truclear Ultra 4.0 device while it assesses the problems, the agency said. The company is also implementing systemic improvements to its corrective and preventive actions system it hopes to verify by January 2016, according to the letter.
The FDA said the problem dates back to August 2012, when Smith & Nephew put a hold on shipments of the Truclear Ultra 4.0 device as it sought to address complaints about loss of visualization and undersized sluff chambers. But some of the devices were re-worked and distributed in spite of the shipment hold, the FDA said.
Smith & Nephew spokesman Joe Metzger told MassDevice.com via email that the shipment hold on the Truclear Ultra 4.0 is still in place.
"We are currently drafting a response and are committed to working with the FDA to resolve all of the issues identified. There have been no issued field actions, recalls, or seizures demanded by FDA as a result of the 483 observations and/or warning letter," Metzger told us. "We are confident that the necessary actions are underway to deliver these improvements."