Israeli drugmaker Teva Pharmaceutical Industries Ltd. (NYSE: TEVA), one of the world’s largest pharmaceutical companies and one with sizeable operations in Orange County, reported Oct. 4 it is temporarily halting production at an Irvine manufacturing plant to address several sanitation and contamination problems listed in an FDA Form 483.
A Form 483 is issued when FDA inspectors observe conditions which indicate “that any food, drug, device or cosmetic has been adulterated or is being prepared, packed, or held under conditions whereby it may become adulterated or rendered injurious to health,” the agency says.
“We have carefully reviewed the 483 and are taking extensive actions to ensure the agency’s observations are fully addressed,” Teva told Reuters. “As a precautionary measure, we temporarily stopped the manufacture of products from the Irvine facility while we conduct a thorough review.”
The specific building being shuttered wasn’t disclosed. Teva has operated several facilities in the Spectrum area of the city over the years, with its main building at 19 Hughes running some 88,000 square feet.
Teva is the second-largest drugmaker in OC with about 300 workers here, according to Business Journal research.
Prior iterations of the company have seen their local facilities come under federal scrutiny over the past dozen or so years.
Cancer Vial Recall
Earlier this year, Teva recalled 2.5 million vials, many of them cancer medications, according to a Bloomberg report. The vials may have been contaminated with mold originating from unrepaired water leaks discovered by FDA inspectors, according to the report.
In addition to the cancer medications, the recalled Teva vials included medications to treat arthritis and schizophrenia.
The FDA inspection also found that the factory workers did not maintain proper protocols to prevent the spread of mold and bacteria, including failing to change into clean scrubs after taking out the trash and using the restroom, according to documents obtained by Bloomberg in a Freedom of Information Act (FOIA) request.
The equipment had also not been tested for sterility or harmful organisms since it was installed 21 years ago.
Teva told reporters it’s currently working closely with the FDA Drug Shortage Staff and FDA Office of Manufacturing Quality as it works through the review and it expects to resume drug production at the facility once the review is complete.
The company didn’t respond to multiple phone calls from the Business Journal requesting comment.
Teva estimates nearly 200 million people take medicine it manufactures every day. In June, the company reported second-quarter revenue rose 1% to $3.9 billion.Â
