Teva has been working to address shortfalls at a manufacturing site in California for years, but a recent layoff notice indicates those efforts are winding down.
Teva Parenteral Medicines is letting go of 305 staffers at its site in Irvine, California, according to a local Worker Adjustment and Retraining Notification (WARN) Act notice. The address provided matches that of Teva’s troubled sterile injectables plant, which has been treading water for more than a decade.
Things most recently came to a head at the plant in October, when Teva told Bloomberg it had temporarily kiboshed production there as it reviewed manufacturing flags from a July 2021 FDA inspection.
While Teva originally said the production pause would be temporary, the company is now pulling out of Irvine altogether.
"The Teva Irvine facility will not resume production and the company is either transferring or ceasing production of medicines made at the site," a Teva spokesperson told Fierce Pharma Monday.
Two key products made at the site—chemotherapy vincristine and antiemetic metoclopramide—have "already been transferred to alternative Teva sites," the spokesperson explained.
"Other product transfers are still being evaluated as we continue to work through the site closure process in Irvine," the spokesperson said.
After an FDA inspection last summer, the agency slapped the site with a Form 483, Reuters reported. What’s more, the Irvine plant’s shortfalls were linked to the recall of 2.5 million vials of Teva drugs used to treat cancer, arthritis and schizophrenia, plus a muscle relaxer used during intubation, Bloomberg said at the time.
In the wake of the plant’s closure, the End Drug Shortages Alliance warned that the production pause could create shortages of up to 25 generic sterile injectables, including five essential medicines for which Teva supplied more than 15% of the market in 2021.
The FDA specifically raised concerns that Teva’s vials might have been contaminated with mold. FDA investigators chided Teva for failing to fix water damage that had been uncovered months earlier. In addition, Teva reportedly failed to maintain proper procedures to keep factory workers from spreading mold and bacteria around the plant, according to inspection documents obtained by Bloomberg through a Freedom of Information Act request.
Last year hardly marked the Irvine plant’s first spot of trouble with U.S. regulators. Back in 2009, the company issued another voluntary shutdown at the California plant following a large recall of the anesthetic propofol.
That closure came after the FDA identified problems with raw material testing, batch failure investigations, equipment cleaning, sanitization and record-keeping.
Teva considered exiting the site once before. Back in 2013, then-CEO Jeremy Levin sketched out a long-term plan to cut $2 billion in costs, part of which included a potential sale of the Irvine plant.
Editor's note: This story was updated Tuesday, Aug. 23, with additional comments from Teva Pharmaceutical.