Amid global anxiety over the novel coronavirus, a newly issued warning letter by the Food and Drug Administration serves as a reminder that quality manufacturing needs to remain a priority.
Consider the March 17 missive sent to Windlas Healthcare, which formulates finished medicines for some of the world’s largest drug makers. The company committed several serious infractions that alarmed the agency following an August 2019 inspection of a manufacturing facility in northern India.
For instance, when the FDA arrived at the facility 30 minutes after announcing its inspection, they saw “numerous employees” moving “cartloads of trash bags containing shredded and torn documents and binders” off the premises. “Upon closer examination, the investigators discovered batch reconciliation forms, cleaning and dispensing logs, training assessments, and scale balance printouts,” the FDA wrote.
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Made even more disturbing with the announcement that FDA is postponing all foreign establishment inspections until further notice.