Increase in 483s, Warnings Show Need to Boost Supplier Controls

Devicemakers saw an increase in 2013 in the number of FDA 483s that cite inadequate supplier controls; the finding is now one of the top five most common 483 findings for devicemakers. The issue has been gaining steam with inspectors for years. In 2010, 84 citations for supplier controls were issued, 98 in 2011, 110 in 2012 and 126 in 2013.
Devices & Diagnostics Letter