The QMN Weekly Bulletin
Medical Devices / Regulatory Affairs / Inspections and Audits / Postmarket Safety

Increase in 483s, Warnings Highlights Need to Improve Supplier Controls

May 16, 2014
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There has been a steady uptick in the number of FDA 483s that cite inadequate supplier controls — from 84 in 2011, to 110 in 2012 and 126 last year. The problem is now one of the top five most common 483 findings for devicemakers.
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