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FDA Flags J&J For Inadequate Oversight Of Consumer Devices

This article was originally published in The Tan Sheet

Executive Summary

FDA shifts its scrutiny of Johnson & Johnson’s OTC drug quality control onto the firm’s consumer devices, including K-Y moisturizers, after finding shortcomings in post-market monitoring and pre-market notification. The agency’s May 22 warning letter does not cite manufacturing issues.

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J&J Will Boost OTC Marketing Once Reliable Production Returns

Johnson & Johnson CEO Alex Gorsky says he expects 75% of OTC products previously recalled to be back on the market in 2013, and the firm will begin prioritizing marketing efforts once a consistent supply of products is restored. The McNeil Fort Washington facility will remain offline another year.

J&J Will Boost OTC Marketing Once Reliable Production Returns

Johnson & Johnson CEO Alex Gorsky says he expects 75% of OTC products previously recalled to be back on the market in 2013, and the firm will begin prioritizing marketing efforts once a consistent supply of products is restored. The McNeil Fort Washington facility will remain offline another year.

J&J Extends Delay In Returning Some OTCs To Market

CFO Caruso says operating under a consent decree with “a third party in the manufacturing facilities with us” makes it “very difficult for us to predict exactly when products will return.” Some products will not return to stores until 2013, significantly later than the original goal to relaunch all recalled liquid OTCs before 2012.

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