FDA Warns Lonza Group Over Device Manufacturing Facility

A Lonza Group Ltd. facility in Walkersville, Md., didn’t adhere to current good manufacturing standards, according to a warning letter posted to the FDA’s website May 9.

An inspection this year showed the Lonza facility, a contract manufacturer of Class II medical devices, revealed several areas of manufacturing noncompliance, the letter, dated April 21, said. Class II devices are considered medium-risk devices.

Warning letters are a good indication of the FDA’s enforcement priorities. The FDA frequently cites companies for violations of current good manufacturing practices (cGMP), with inadequate corrective and preventive action (CAPA) procedures a top category of violation. ...