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Warning given to Teva’s Banned Hungary Manufacturing Facility by USFDA

The US Food and Drug Administration (FDA) has warned Teva’s Hungary-based manufacturing site, citing deficiencies in manufacturing operations and laboratory controls, as well as the company’s data integrity program.

In Jun 2016, the site was banned by FDA from shipping products to the US except for 2 drugs that are infection treatment Amikacin and the chemotherapy Bleomycin. Teva in its response to the letter said that it “has undertaken corrective actions to address both the specific concerns raised by investigators as well as the underlying causes of those concerns. Communication with the FDA is ongoing.”

Teva received a Form 483 for good manufacturing practice violations that precedes a warning letter, for the site in January, as well as in 2007. The company also voluntarily halted all production at the site in January.


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