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Johnson & Johnson, McNeil Consumer Healthcare

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Company: Johnson & Johnson, McNeil Consumer Healthcare
Plant: Skillman, NJ
Warning letter: May 22, 2012

The FDA's issues with the Skillman plant are not particularly notable in and of themselves. Among other things, the agency cited the plant for failures over its handling--or lack of handling--of complaints about K-Y Liquibeads Vaginal Moisturizer. The plant racked up 227 complaints in 18 months about the product that were not properly investigated, including nearly 70 that had some medical aspect to them.

What makes it remarkable is that only last year McNeil Consumer Healthcare signed a consent decree with the FDA after it had to recall and destroy tens of millions of consumer products that were manufactured at three other plants for a laundry list of problems. The recalls and lost market share have reportedly cost the company $1.5 billion and it has to invest more than $100 million to retool the Fort Washington, PA, plant.

The Skillman plant was not included in last year's consent decree and any company the size of Johnson & Johnson will face manufacturing issues at some point, but the failures outlined in the warning letter involve things that all manufacturers are expected to do at any plant. They include expeditiously handling complaints, properly testing and letting the FDA know if you are making changes to processes. Some were repeat offenses.

But what makes the warning letter even more notable is that it was delivered shortly after CEO Alex Gorsky took over at the April stockholders meeting where he very publicly pledged that the consumer unit would do better and the company would restore the faith of customers. Ouch.

The company did recall 69,000 packages of the vaginal lubricant because the FDA also says in its correspondence that the changes McNeil made in the "product extension" were extensive enough to require premarket approval or an exception.