FDA Notes Supplier Control Issues in Warning to German Devicemaker

Weber Medical GmbH, a German manufacturer of laser therapy equipment, failed to follow its procedure requiring suppliers to have a quality management system in place, according to an FDA warning letter. One of Weber’s suppliers at the time of the Jan. 14 to Jan. 17 inspection did not have a quality management system, and the company’s contract agreement did not include FDA quality system regulations, says the May 2 letter, posted recently online.
The GMP Letter