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.