FDA Bans Imports From Teva’s Hungary Plant Except Two Drugs in Shortage
Posted 02 June 2016 | By
The US Food and Drug Administration (FDA) late last week announced an import alert prohibiting drugs made at the Gödöllő, Hungary-based manufacturing site from entering the US.
However, Teva spokeswoman Denise Bradley told Focus 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.
“The import alert was issued on May 27 and we are now in the process of determining next steps relative to our production start-up in Godollo,” Bradley said.
FDA did not offer any additional information on why the import alert was issued, though 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 $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.
“We are not aware of any reports of adverse events or safety signals related to FDA’s observations of our manufacturing plant in Godollo,” Bradley added, noting that distribution of products outside the US will continue.
Import Alert 66-40