FDAnews Drug Daily Bulletin

Quality Issues Lead to Shuttering of Teva’s Hungarian Plant

June 8, 2017

Teva is expected to close its facility outside Budapest, Hungary, following a string of quality control problems and major recalls.

In October, Teva received a warning letter from the FDA citing the company for sterility testing and contamination issues at the plant, which opened in 2012. The letter said Teva did not thoroughly investigate sterility test positives and investigations did not adequately assess the hazards in aseptic manufacturing operations.

In the months before the warning letter, Teva recalled more than 100,000 units of four injectable drugs produced at the Hungarian plant, which had previously been shut down by the FDA for manufacturing violations, with all but two of its drugs—the cancer treatment bleomycin and antibiotic amikacin—placed on an import alert.

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