FDA Flags J&J For Inadequate Oversight Of Consumer Devices

 
• By Dan Schiff

Though the firm claims to have come a long way in improving management of OTC pharma quality control since its 2009/2010 recalls, a May 22 warning letter regarding post-market monitoring and pre-market notifications for K-Y moisturizers suggests consumer devices are not getting the same level of attention.

Two years into its OTC drug quality-control remediation program, Johnson & Johnson has received an FDA warning letter concerning the firm’s handling of consumer complaints for consumer products regulated as devices.

The May 22 letter cites violations related to K-Y brand moisturizers, O.B. tampons and Reach dental floss and suggests that...

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• By David Ridley

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