A warning letter?! It is up to the manufacturer to provide information to the FDA. I also did not hear of any fine against Medtronic. What will force them to cleanup their act or is Medtronic to big of a ship to steer?

“It took almost two years from when the missing propellant was initially identified to conduct a recall.”

“In a statement, Pat Mackin, president of the Cardiac Rhythm Disease Management business and senior vice president at Medtronic said, quoted the Business Journal, “Medtronic remains committed to providing the highest quality products to our customers and is working with FDA to resolve all remaining issues as quickly as possible…”

“FDA is concerned with your failure to initiate a recall for devices affected by the propellant problem in a timely manner,” the warning letter, dated June 1, states. “It took almost two years from when the missing propellant was initially identified to conduct a recall.”

“According to the letter, training records indicated that the employee who evaluated MiniMed pump reports only had a high school diploma with some additional in-house training.”

http://www.newsinferno.com/archives/13953#more-13953

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