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German Spinal Implant Maker Warned for Audit, CAPA Slips

September 20, 2013
Ulrich GmbH, a German manufacturer of spinal implants and accessories, has been warned for audit and CAPA violations, including a couple of repeat violations from a 2005 inspection. The company’s supplier assessment procedure requires annual supplier evaluations, but the company failed to conduct some of those required, according to the Aug. 15 letter posted recently online.
Devices & Diagnostics Letter