PDA Letter Article

Visual Inspection Remains Critical

by John Shabushnig, PhD, Insight Pharma Consulting, and Markus Lankers, PhD

PDA VI Course 2008 065 edit

Visual inspection and the detection of particles remain at the forefront of product manufacturing control, quality assurance and regulatory compliance. From 2010 to 2017, 48% of all injectable product recalls in the United States were associated with visible particulate matter. Particle-related recalls reached a high of 25 in 2014. Since then, the number of recalls and FDA 483 observations has continuously decreased. This may be due, in part, to the introduction of improved regulatory guidance as found in USP <790> Visible Particulates in Injections and <1790> Visual Inspection of Injections, in addition to better understanding and greater emphasis by the pharmaceutical industry.