Minneapolis / St. Paul Business Journal by Katharine Grayson, Staff reporter
St. Jude Medical Inc. has received a warning letter from U.S. Food and Drug Administration related to operations at its manufacturing plant in Sylmar, Calif.
The Little Canada-based medical-device maker included the letter, portions of which were redacted, in a U.S. Securities and Exchange Commission filing. St. Jude CEO Daniel Starks warned investors last week that the company might receive a warning following an inspection of the facility, where it makes cardiac rhythm management products.
St. Jude (NYSE: STJ) said in the filing that the FDA did not identify a “specific issue regarding the clinical or field performance of any particular device.” The company also said it doesn’t expect costs associated with addressing the agency's concerns will have a “material impact” on its financial results.
The FDA's letter had 11 “observations,” including several related to “verification testing,” canine testing and the company's corrective and preventive actions policies.
St. Jude said it will respond to the FDA’s letter no later than Nov. 7.