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FDA and Customs Monitoring of International Purchasing: What You Need to Know

By John Gagliardi

Medical device manufacturers own responsibility for every step of their global supply chain when it comes to buying raw materials, finished devices, components and services from overseas suppliers. Therefore, when a manufacturer chooses to utilize overseas or domestic suppliers, it should ensure control over any product or service obtained from such suppliers as defined within their Quality Management Systems. Based upon risk, these controls may extend further if a supplier subcontracts work. 

While manufacturers are responsible to comply with the 21 Code of Federal Regulations (CFR) Part 820 and ISO 13485: 2016 for Purchasing Controls and Acceptance Activities, it’s important they understand that FDA and U.S. Customs play instrumental roles in the monitoring of quality systems and products, respectively. Random inspections are done before products cross the border into the U.S., and inspections of medical device QMS are ongoing.

With that knowledge, this article outlines the roles of individual manufacturers selling in the U.S., FDA and U.S. Customs, as they relate to the increasing scrutiny of international purchasing controls.

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