J&J's Gorsky sees McNeil U.S. issues with FDA coming to a close

Johnson & Johnson ($JNJ) CEO Alex Gorsky has been saying for a year that the company was going to whip quality problems in its McNeil Consumer Healthcare division and get production of popular consumer OTC brands on track. He now thinks that by year's end it can start ticking off the punch list with the FDA at its Fort Washington, PA, manufacturing site, setting the stage for shedding a federal consent decree.

"We submitted our plan, the FDA accepted it, and now, literally, what you have are requirements that they have to check off," Gorsky told The Philadelphia Inquirer. "We're meeting those, we're on track, and very hopeful that near the end of this year we'll be able to have the FDA review the entire package to get it back in operation."

The plant was closed in 2010 after J&J recalled tens of millions of consumer products, including its popular Tylenol and Motrin products. In 2011, J&J's McNeil Consumer Healthcare signed an FDA consent decree over that plant and two others. It has spent more than $100 million to upgrade its key OTC plant. The Fort Washington plant is not producing, but the company has been ramping up production at the other two to try to keep popular brands before consumers.  

While Gorsky says significant progress has been made in the U.S., its consumer health operations have run into problems elsewhere around the world of late. There is a criminal investigation in South Korea after J&J's Janssen unit released some Children's Tylenol products that contained excessive levels of acetaminophen. Authorities were reportedly upset that the plant waited a month to report the mistake.

Now there are reports that China had a meeting with J&J officials and has taken the company to task for reportedly being slow to pull products from mainland China that had been recalled in other markets. J&J denies that contention, Pharmalot reported. A spokesperson told Pharmalot that the company treats all parts of the world equally. J&J said: "There may be instances when quality actions initiated in other parts of the world do not affect a specific country because the products in question are not sold there or the facilities where quality matters have arisen do not manufacture products for that country."

- read the Philadelphia Inquirer story
- here's the Pharmalot report

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