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WSJ blog reports FDA weighing penalties against J&J

Plant violations, weak responses to consumer complaints, and buying suspect packages off store shelves concern the FDA.

A May 28 report on the Wall Street Journal’s Health Blog painted a not-so-sterling picture for Johnson & Johnson—its McNeil Consumer Healthcare unit in particular.

The article pointed to a “pattern of noncompliance” with Good Manufacturing Practices stemming from J&J’s recall of children’s liquid medications. The company’s Fort Washington, PA, plant was singled out for “improper handling of raw materials, a weak response to consumer complaints and a failure to follow up on tests showing infants’ Tylenol contained too much active ingredient.” No serious health effects have been linked to the problems, said blogger Katherine Hobson in the article. However, the story also revealed that in late 2008, J&J hired a contractor that “actually told its workers to buy up all the suspect packages in the stores, acting as if they were regular consumers.”

McNeil has developed a Web site with product recall information. In a “frequently asked questions” section, the site informs visitors how to find lot number and expiration date on the packaging, how to return product for a refund, etc.

There’s never a good time for a product recall, nor for a “weak response” to the U.S. Food and Drug Administration, but J&J/McNeil’s timing couldn’t be much worse given the agency’s growing clout in the current administration. Legal columnist Eric Greenberg, who recently wrote about learning lessons from J&J’s product recall, told attendees at last week’s Healthcare Packaging Conference & Workshops event in Princeton, NJ, to expect FDA to issue a greater number of FDA Warning Letters this year.

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