For nearly 30 years the heroic story of Johnson & Johnson quick action to remove Tylenol from the shelves after a deadly tampering incident has been folklore in business circles. So what do we make of the news today that The Food and Drug Administration is considering “additional enforcement actions” that might include criminal penalties against the Johnson & Johnson unit that makes Tylenol.

As reported by the Wall Street Journal:

According to written testimony of the FDA’s principal deputy commissioner prepared for a U.S. House committee hearing later Thursday about a wide-ranging recall of children’s Tylenol and other medicines, the agency said it was working with the company “to address its systemic quality issues.”

On April 30, McNeil Consumer Healthcare announced a recall of more than 40 kinds of liquid formulations of infant and children’s Tylenol, Motrin, Zyrtec and Benadryl products because of manufacturing problems at its Fort Washington, Pa., plant, which remains shut down.

“FDA is also considering additional enforcement actions against the company for its pattern of non-compliance which may include seizure, injunction or criminal penalties,” Joshua Sharfstein said. “Over the last several years, FDA has had growing concerns about the quality of the company’s manufacturing process,” he said.

What happened to the fabled J&J Credo? What is going on within the culture that is causing J&J to be seen by the FDA as slow to address quality issues?

Every manufacturing company faces quality issues that impact production. Companies with a healthy ethical culture however have the ability to respond quickly to issues internally, as well as keep regulators and externally stakeholders appropriately informed.

After seeing the issues faced this year by stalwart brands such as Toyota and now J&J, one wonders whether their core values are being taken for granted?

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David Gebler is the President of Skout Group, an advisory firm helping global companies manage ethics risks.  Send your thoughts and feedback to dgebler@skoutgroup.com.