Teva is reportedly putting a temporary halt on production at its sterile injectables manufacturing site in Irvine, California. The move comes in response to FDA concerns about contamination issues at the facility that triggered drug recalls earlier this year, Bloomberg reports.
The manufacturing problems stem from a July FDA inspection that found Teva hadn't repaired water damage at the site and hadn't maintained procedures to keep factory workers from spreading mold and bacteria, Bloomberg reports. Further, the company failed to make sure equipment it installed more than two decades ago to test for sterility and harmful organisms worked properly, according to an FDA report cited by the news service.
In response, the company has temporarily shuttered production there, Bloomberg and Reuters report.
"As a precautionary measure, we temporarily stopped the manufacture of products from the Irvine facility while we conduct a thorough review," a spokesperson told Reuters.
Before the plant shutdown, Teva recalled 2.5 million vials of drugs used to treat cancer, arthritis, schizophrenia and a muscle relaxer used during intubation, Bloomberg reports. Those recalls were triggered by FDA concerns that the vials may have mold contamination.
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The company didn’t immediately respond to a request for comment from Fierce Pharma.
Problems with the Irvine facility go as far back as 2009 when Teva issued a voluntary plant shutdown in the wake of a large recall of the anesthetic drug propofol after the FDA found problems with raw material testing, batch failure investigations, equipment cleaning and sanitizing and record keeping.