Earlier this month, Novartis took the surprising step of voluntarily suspending production of two therapies that use nuclear medicine to target and treat cancer cells, and also halted clinical trials for one of the treatments.
At the time, the company explained it was doing so “out of an abundance of caution” in order to “address potential quality issues identified in its manufacturing processes” at facilities in Millburn, N.J., and Ivrea, Italy. No further explanation was offered, although a spokesperson did acknowledge regulators cited the company last fall for issues at the New Jersey plant.
To what extent the quality control problems found by the Food and Drug Administration had contributed to the decision to suspend production is unclear. But the matters that were raised by the agency — and the responses that Novartis subsequently provided — illustrate a series of production challenges the company has faced, according to documents reviewed by STAT.
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