Teva laying off 500 at struggling sterile injectables plant in Hungary

Teva is reportedly laying off 500 at it sterile injectables plant in Hungary that was bashed in an FDA warning letter last fall.

Teva is giving up on its sterile injectables plant in Godollo, Hungary, that halted production last year after the FDA found manufacturing failings. The generics maker is laying off hundreds of workers in the next few months and will sell or close the plant by the end of next year.

A Teva spokesperson Wednesday confirmed reports citing Hungarian media about its plans to shed the facility on the outskirts of Budapest. She said about 500 workers are at risk of losing their jobs as the company winds down production at the site with the intent of selling or closing the plant by the end of 2018.

"At the same time, it’s important to note that Teva remains committed to operating in Hungary and our plants in Debrecen and Sajóbábony, as well as our commercial organization – with more than 2,000 employees -- are not included in this plan," spokeswoman Grace Ann Arnold said in an email. "Teva will also continue its ongoing investment in local production and R&D activities in Debrecen." 

She said the reduction is part of the company’s global network operations strategy to "align production capacity with market and patient demand globally."

The announcement comes just weeks after Israeli media reported that the financially struggling and management-challenged drugmaker was looking to cut up to 6,000 jobs.  A company spokeswoman at the time confirmed plans to reduce costs, but said Teva "does not have a headcount target" because the number of job cuts would depend on the "right-sizing of each individual area of our business."

Related: Struggling Teva said to plan thousands of job cuts as it hunts for CEO

Today's announcement follows a year of burgeoning issues for the nearly new plant, which Teva opened in 2012 to expand its injected drug capacity. FDA investigators found a host of sterility issues during an inspection in January 2016 that they said put the plant's drugs at risk for contamination. The next month, Teva halted production at the facility while it determined how best deal with the issues. 

The FDA then decided the were severe enough that it added the plant to its import alert list, banning all but two of its drugs--the cancer treatment bleomycin and antibiotic amikacin, which were exempted to avoid shortages. Teva recalled all other unexpired drugs from the plant that were still in the U.S.

Then in October, the FDA issued a warning letter laid out its findings and gave the company a long list of marching orders that it said had to be completed before the plant will be allowed to again ship product to the U.S.

Related: FDA cites 'significant' sterility concern at Teva injectables plant

Teva at the time said it was working diligently to address all of the FDA concerns, while also is working to replenish critical and priority products as quickly as possible. It said manufacturing for some products might be moved to other suppliers.