This post was contributed by FDAImports.com Regulatory Consultant, Walt Brittle
Recently, Dan Starks, CEO of St. Jude Medical, Inc., announced to the media and investors that their Sylmar plant would likely receive a Warning Letter in response to an inspection prompted by St. Jude’s 2010 recall of faulty wires used in defibrillators. The company hoped to inform and reassure investors with the announcement that the Warning Letter was little more than FDA “exercising its role in a very vigorous and robust way.” As predicted, the plant did receive a Warning Letter (January 10, 2013), but it was certainly more than a routine exercise of FDA’s role; the letter identified more than a dozen significant areas in which the plant was deficient (link below). One can imagine the stress in the Corporate Board Room and among investors after the Warning Letter went public.
St. Jude’s experience reveals several things: FDA’s value in quality system problem-solving, the importance of internal auditing before inspections, and the difficulty in assuring that medical devices meet all the specifications for design, development, and manufacturing. Don’t let complacency creep into your quality system; be careful to maintain a vigorous internal audit program! Every quality system must be diligently maintained – especially the more sophisticated ones. It is nearly impossible for QA management to maintain a system unless top management is genuinely committed to making product safety a number one priority.
Don’t wait for FDA to “exercise its role in a very vigorous and robust way,” like it did in the case of St. Jude. It’s much better to conduct internal audits with the same care that an FDA inspector would take, and be able to fix problems before FDA calls you out on them. FDAImports.com assists medical device manufacturers all over the world with the compliance strategies needed to successfully bring a product to market.
Source
www.fda.gov/ICECI/EnforcementActions/WarningLetters/ucm335444.htm
