Federal investigators have issued a warning to Smith & Nephew PLC about quality control problems that need to be corrected at a plant that manufactures hip replacement implants.
The FDA sent a warning letter to the U.K. company on December 21, calling for corrective actions at its Tuttlingen, Germany, production facility. The plant is responsible for the manufacturing of the R3 Ceramic Acetabular System, but the FDA says that its processes to validate and verify the quality of its products lack in a number of areas.
The letter stems from FDA inspections of the plant that occurred in July. The company initially sent a response to the FDA addressing its concerns, but the response was deemed insufficient, according to the warning letter.
Among the problems that the inspectors found was a failure to confirm the validity of the plant’s minimum and maximum settings for a titanium ring press. Inspectors also said that the plant failed to verify that corrective actions taken to fix a problem where radiation-sterilized parts were not getting enough radiation were actually working. When the problem recurred later, the plant blamed it on employees not following the new procedures.
The FDA inspectors said that attempts by the plant to address the problems had failed because there were no procedures to make sure that the fixes were actually working. As a result, a number of problems that the plant had supposedly addressed cropped up again.
The company has 15 days to respond to the letter. If it fails to respond or adequately address the FDA’s concerns, its parts could be seized when they try to ship them to the U.S. without warning.
In 2007, Smith & Nephew agreed to pay $28.9 million to the U.S. Department of Justice over kickbacks it paid U.S. doctors to implant their hip and knee devices into patients. As a result, the company underwent 18 months of federal monitoring.