FDA spanks J&J McNeil plant over complaint failures

Folks at Johnson & Johnson ($JNJ) can talk the talk, but when it comes to manufacturing cGMPs, it appears they still don't walk the walk.

The FDA has delivered another warning letter to J&J's McNeil Consumer Healthcare unit. Among other things, the agency cited it for failures at its Skillman, NJ, plant over its handling--or lack of handling--of complaints about K-Y Liquibeads Vaginal Moisturizer. The letter, posted this week on the FDA website, says 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.

The company last year signed a consent decree with the FDA after it had to recall and destroy tens of millions of consumer products for a laundry list of problems that were manufactured at three other plants, Bloomberg reminds.

A spokeswoman for McNeil says the unit takes the current matter seriously and will work with the FDA to resolve any issues. But it comes only weeks after Alex Gorsky told shareholders that his top priority as he took over as CEO is resolving manufacturing problems so Johnson & Johnson can get its once well-regarded consumer brands back in consumers' hands, and presumably other parts of their anatomies.

It also follows the public shifting of management to emphasize just how seriously the company took all of the OTC problems. At the same time that Gorsky was named CEO in February, the company acknowledged the retirement of 35-year veteran Patrick Mutchler, who had been put in charge of overseeing the McNeil Consumer Healthcare 10 months earlier. Those responsibilities were handed off to Roberto Marques, who headed J&J's consumer businesses in North America.

The Skillman plant was not included in last year's consent decree and any company the size of Johnson & Johnson will face some manufacturing issues at some time, but the failures outlined in the warning letter are the kinds of 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. For example, the FDA says "The K-Y Liquibeads Vaginal Moisturizer product label states that the product is compatible with latex condoms." But the proof of that was a study that "did not include, K-Y Liquibeads Vaginal Moisturizer product and did not assess latex condom compatibility with fractionated coconut oil and fractionated coconut oil-lecithin, both of which are used in" the K-Y Liquibeads formulation.

In other words J&J didn't walk the walk.

- read the warning letter here
- see Bloomberg's take

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