FDA Tells Sicor to Improve Procedures
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Sicor Inc. has received a warning letter from the Food and Drug Administration asking it to improve procedures at a pharmaceutical plant in Irvine that produces injectable drugs for anesthesia and for treating cancer.
Sicor’s Gensia Sicor Pharmaceuticals Inc. unit said Friday that it received the letter asking it to improve its system for documenting that tanks used to mix drugs are properly cleaned and to improve procedures for backing up information stored on computers.
“Obviously this is serious. We need to make some adjustments and corrections,” Sicor spokeswoman Laurie Little said.
The warning was issued after an inspection last month, part of the FDA’s review of a drug-approval application. The letter won’t affect production at the factory, one of three plants where Sicor makes and processes drugs, Little said.
“We’re still in production and will be meeting all our deadlines,” she said. “We’ll be working to respond to the FDA by the end of July.”
Shares of Irvine-based Sicor were unchanged at $4. The company disclosed the warning after the close of U.S. stock exchanges.
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