Manufacturing lines at Teva Pharmaceutical’s Irving, Calif. plant have come to a standstill while the company works on remedying issues with the FDA.
The company announced this week that it received a Form 483 from the agency, but did not divulge details about the agency’s observations.
“We have carefully reviewed the 483 and are taking extensive actions to ensure the agency’s observations are fully addressed,” the company told Reuters. “As a precautionary measure, we temporarily stopped the manufacture of products from the Irvine facility while we conduct a thorough review.”
The news follows a report from Bloomberg saying that the company has been forced to recall 2.5 million vials of drugs, many of which are cancer medications. According to the report, the FDA inspected many vials and uncovered mold contamination related to water leaks.
The company said it is working to reduce the impact the production halt could have on patients while reviewing quality protocols with the FDA.
The same Irving plant was also slapped with an FDA warning letter in 2010 after a July 2009 inspection found that the company failed to test each lot of raw materials used to produce the sedative propofol for certain toxins.