QMSR removed the exemption that long kept supplier audit records out of FDA investigators' reach. What that means for supplier and outsourcing controls under ISO 13485, and how to get supplier audit files inspection-ready.

In February 2008, hospitals across the United States began seeing something that almost never happens with heparin, a blood thinner used in millions of procedures every year: patients going into sudden, severe allergic-type reactions — hypotension, nausea, shortness of breath — within minutes of receiving it. The FDA would eventually trace the cause to a contaminant called oversulfated chondroitin sulfate, added somewhere upstream in the crude heparin supply chain in China, a