A California plant operated by Little Canada, MN–based St. Jude Medical recently won a reprieve from the FDA over violations cited following a plant inspection in 2012. The facility manufactures the company’s next-gen Durata defibrillator leads.
In its Form 483 warning letter, the FDA had cited 11 quality control and documentation issues at the Sylmar, CA, plant. According to information from an SEC regulatory filing, the company decided to ignore the warning letter.
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