This post was contributed by FDAImports.com Senior Regulatory Advisor, Tom Knott
FDAImports.com recently saved a U.S importer of medical components the substantial cost of unnecessary laboratory testing for one of their products. When the U.S. Food and Drug Administration (FDA) found Quality System issues with the importer’s foreign manufacturer, the Agency sent that foreign facility a Warning Letter placing all of their products on Import Alert 89-04, “Detention of Devices from Firms that Have not Met Device GMPs.” Immediately FDA began to automatically detain the importer’s shipments of components, creating a significant problem for the importer and foreign contract manufacturer.
At this critical moment, the team at FDAImports.com was able to intervene and demonstrate to FDA the medical necessity of one of the components. As a result, FDAImports.com obtained FDA release of the product pending sterility testing. However, FDA initially required each lot undergo a variety of other tests as well sterility. This is status quo for FDA; however, FDAImports.com proved that due to characteristics inherent in the manufacturer’s processes, these products did not require the additional tests. As a result, FDA released the product from detention, permitted distribution and the importer’s costs were reduced significantly – something that never would have happened without proper application of law and regulations and science to an FDA automatic detention.
At least one lesson to learn is that companies need to advocate for principles they know are logical and scientifically correct as well as make legal and regulatory arguments. FDA often does place unnecessary requirements on companies; it’s easy for them to do and the burden flips over to the company to help the Agency get it right. Another important lesson is that companies need a science, regulatory and legal compliance partner on their side – A partner like FDAImports.com – for times when FDA wrongly accuses, fines, detains or refuses your product.
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