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Tweaks to FDA’s warning letter ‘close-out’ program?

This article was originally published in The Silver Sheet

Executive Summary

Amrex-Zetron became the second manufacturer to receive an FDA quality-related warning letter "close-out" correspondence, on April 30. The close-out officially resolves an April 14, 2009, warning letter that cited the firm for a variety of quality system troubles. The close-out letter appears to be a break from FDA's decision to issue close-out letters only for warning letters issued after Sept. 1, 2009. "Things are happening a little different in the different [FDA districts], so we're trying to circle the wagons and trying to get a consistent policy," FDA/GMP expert Kim Trautman told "The Silver Sheet" May 5 at the MedCon medical device conference in Cincinnati. "We're always worried about trying to be consistent no matter what it is. So if something is out there that is not consistent with what other people are doing, then we just want to try to get the process in order the best we can." Steve Silverman, senior advisor to the CDRH director, says it's possible that FDA could eventually change the close-out letter policy. "If the program is not designed for warning letters issued before September 2009 and [Amrex-Zetron's close-out letter] is a one-off, I don't think that precludes us from evaluating, as we get more experience on the information about the program, applying the start date to a point earlier than September 2009," Silverman said at MedCon

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