Teva temporarily padlocks a plant after FDA cites it for contamination
After FDA investigators unveiled a list of problems that were found at a Teva Pharmaceuticals plant in Irvine, CA, including mold stemming from water leaks, the company said it will halt production at that site until it is able to meet quality expectations.
A Teva spokesperson confirmed the temporary manufacturing stoppage Monday morning in an email to Endpoints News, saying that that production will resume after a review is conducted.
“In an effort to minimize impact on patients, we are working closely with the FDA Drug Shortage Staff and FDA Office of Manufacturing Quality as we work through this review,” the spokesperson wrote. “We will ensure that the agency and relevant customers are aware of our progress as we move forward.”
The Form 483 from the FDA led to the recall of more than 2.5 million vials of drugs that might not be sterile, Bloomberg reported Monday morning. In February, Teva pulled 1.5 million vials off of the shelves after mold was detected in the air of manufacturing areas.
A July inspection found that untreated water damage led likely to the mold generating in the walls, and minimal steps had been taken to prevent the further spread of mold and bacteria throughout the site.
According to Bloomberg, which said it obtained the inspection documents in response to a Freedom of Information Act (FOIA) request, the benches that were used to change into scrubs were dirty. Additionally, factory workers often wore scrubs outside the building to take out the trash and use the restroom, failing to change them again once they re-entered the manufacturing site. Equipment had not been tested for sterility or harmful organisms since it had been installed 21 years ago, Bloomberg reported.
The statement from Teva said:
We have carefully reviewed the 483 and are taking extensive actions to ensure the agency’s observations are fully addressed. All Teva facilities have strict and comprehensive quality protocols in place and as part of the work we are doing in response to the recent Inspection, we will further enhance our efforts to ensure that we meet or exceed all regulatory requirements.
The announcement comes as President Joe Biden’s administration has attempted to persuade Big Pharma to ramp up domestic drug production. Generic drugs make up 90% of Americans’ medications, while nearly 70% of active pharmaceutical ingredients are made outside the US, a White House report says. Last week, a bill was introduced in the US House of Representatives that would create a national stockpile of APIs to prevent supply chain shortages in the future.