Teva months from restarting production at Hungary plant banned by US FDA
The facility in Godollo has been under scrutiny since January when US Food and Drug Administration (FDA) inspectors identified deviations from current good manufacturing practice (cGMP).
Teva declined to share details of the visit, but did say inspection prompted it to halt production and recall a number of drugs already shipped to the US.
A company spokesman told us “at the time we recalled all in-date lots of four different drugs: argatroban, linezolid, eptifibatide and ondansetron in the US.”
He added that: “We are working around the clock to re-start manufacturing operations in Godollo and expect that to occur in the coming months."
According to the FDA's latest enforcement report Teva began pulling the products in June. The agency designated the four recalls as class II last week.
A follow-up inspection of the Godollo site by the US agency in May earned the plant an import alert.
Under the alert Teva was banned from shipping all but two of the drugs made at the site – the antibiotic amikacin sulfate and the cancer medication bleomycin – to the US.
At the time both medicines were deemed to be in short supply by the FDA.
However, in July Teva withdrew seven lots of amikacin sulfate in July, shortly before the drug was removed from the agency’s shortage list on August 9,