FDA Flags J&J For Inadequate Oversight Of Consumer Devices

04 Jun 2012

• By Dan Schiff

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.

FDA shifts its scrutiny of Johnson & Johnson’s OTC drug quality control onto the firm’s consumer devices, finding sufficient shortcomings in post-market monitoring and pre-market notification to warrant a warning letter.

J&J and subsidiary McNeil Consumer Healthcare say they have come a long way in improving management of OTC pharma...