German-based devicemaker DRG Instruments drew a warning letter from the FDA and the agency said it would refuse entry of the company’s medical devices to the U.S. market because they were adulterated and misbranded.
An October 2016 inspection of the firm’s manufacturing facility in Marburg revealed GMP nonconformities in process control procedures, CAPA reports and employee training. The agency was not satisfied with responses it received to a Form 483 report issued after the inspection.
The firm reworked ELISA microplates in an attempt to address quality control test failures without establishing written procedures for storing or preparing their antibody vials and solutions, the agency said. A CAPA report reviewed during the inspection showed manufacturing errors that led to many low patient results were caused by a failure to update manufacturing procedures after a design change, the agency said.