FDA Warns Teva’s Banned Hungary Manufacturing Facility

Regulatory NewsRegulatory News
| 19 October 2016 | By Zachary Brennan 

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

The warning letter, sent on 14 October, followed FDA’s eight-day current Good Manufacturing Practices (cGMP) inspection of the facility, in January 2016.

Teva said in an SEC filing 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.” The Israeli drugmaker also said it will respond to the letter on 4 November.

Back in June, the site was banned by FDA from shipping products to the US, though a Teva spokeswoman told Focus at the time that the ban does not include two drugs that are medically necessary and currently in short supply in the US. Those two drugs are the infection treatment Amikacin and the chemotherapy Bleomycin.

Teva received a Form 483, usually the document outlining initial 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.

The $110 million manufacturing facility, originally opened in 2012, was used to increase the company’s capacity for producing sterile injectable drugs, and with six production lines, the 15,000-square-meter plant has the capacity to make 160 million to 200 million units of injectable medicines each year.


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