Last week, St. Jude Medical ($STJ) warned investors that the FDA might take issue with its Sylmar, CA, facility, and now the agency has issued a note detailing its concerns with the company's manufacturing practices.
The FDA conducted a quality inspection of the plant last month and has now issued a Form 483, chiding St. Jude over its device design protocol, personnel training and handling of complaints, among other things. The form lists only the concerns cited by the inspector and does not constitute an official warning letter, which may or may not ensue.
The Sylmar plant manufactures cardiac rhythm devices, including ICD leads--products with which St. Jude has a checkered past. When CEO Dan Starks mentioned last week that he expected a full warning letter for the facility, analysts and investors were understandably alarmed, calling to mind the massive recall of St. Jude's Riata leads.
St. Jude attached a heavily redacted copy of the notice to its most recent SEC filing, saying that it plans to fully cooperate with the agency and keep the plant up and running as it prepares its response. St. Jude has already started working to correct the 11 issues cited in the note, the company said in the filing, and it doesn't expect the costs of addressing the problems to have an impact on earnings.
"It is important to note that none of the observations identified a specific issue regarding the clinical or field performance of any particular device," St. Jude said in its filing. "... The company takes quality and product safety very seriously and is committed to fully resolving the quality system observations identified during this most recent FDA inspection."