The FDA has issued a “Warning Letter”, dated January 10, 2013, to St. Jude Medical, a company that manufactures many medical devices used throughout the world, including implantable cardiac devices. In the letter, St, Jude was advised that, during a 2012 inspection of St. Jude’s Sylmar, California facility, FDA investigators determined that St. Jude manufactured implantable cardiac leads which were “adulterated” under federal law, in that the methods used in, or the facilities or controls used for, their manufacture, packing, storage, or installation are not in conformity with the current good manufacturing practice requirements of the Quality System regulation found at Title 21, Code of Federal Regulations (CFR), Part 820. While St. Jude has responded to some of the concerns addressed by the investigators,the FDA has concluded that the responses were inadequate.
The FDA has asked St. Jude to provide written notice within fifteen business days from the date they received the warning letter of the specific steps St. Judey has taken to correct the noted violations, as well as an explanation of how the firm plans to prevent these violations, or similar violations, from occurring again. They asked that St. Jude include documentation of the corrections and/or corrective actions (including any systemic corrective actions) that the firm has taken. If St. Jude’s planned corrections and/or corrective actions will occur over time, they are to include a timetable for implementation of those activities. If corrections and/or corrective actions cannot be completed within fifteen business days, St. Jude was asked to state the reason for the delay and the time within which these activities will be completed. Finally, the warning letter notes that St. Jude’s “response should be comprehensive and address all violations included in this Warning Letter.” We’ll see…but it looks like the FDA is finally running out of patience with St. Jude.