The Food and Drug Administration found "serious regulatory problems" with several devices made by Boston Scientific, including its Taxus drug-eluting stents, during a 2-month-long inspection of the company's plant in Quincy, Mass.
In an Aug. 10 warning letter, the FDA criticized Boston Scientific for shipping unacceptable devices to hospitals, failing to ensure that an effective quality system had been established, and failing to analyze and document quality-control problems, among other shortcomings. At deadline, Boston Scientific had not responded to a request for comment.
The FDA, which posted the letter online Tuesday, said the violations uncovered by the inspection March 28 through May 20 could be "symptomatic of serious underlying problems." Read the letter.