In a detailed analysis in Fortune Magazine’s online edition, Johnson & Johnson’s quality control problems are outlined by Fortune reporter Mina Kimes. The article describes the problems J&J faced with the acquisition of Pfizer’s consumer health care unit and the changes in J&J’s McNeil Laboratories over-the-counter subsidiary when Pfizer’s unit was rolled into McNeil. “Over 10 years it became a completely different company,” a former McNeil employee is quoted by Fortune. Quality control fell by the wayside as McNeil was moved from J&J’s pharmaceutical division to the consumer products division.
Lax standards led to McNeil receiving a lengthy Form FDA 483, Inspectional Observations, in 2004 as problems continued to mount. Aggressive cost cutting led to the quality control headaches and the department’s lack of effectiveness. According to the Fortune article:
“There were no wholesale layoffs in quality control. Instead experienced staffers were repeatedly laid off and replaced with newbies who mostly lacked technical pharmaceutical experience.”
The downward spiral led to J&J’s current problems with recalls and appearances before Congressional committees. The Fortune article includes a video where J&J CEO Bill Weldon apologizes for the quality control failures. It looks like J&J’s QC headaches are not going to go away in the immediate future. Maintaing quality standards takes a consistent approach that the company has let fall by the wayside. The article also shows how mergers and acquisitions in the pharmaceutical industry can lead to a lot more than increased profits.
Update: Johnson and Johnson is getting negative quality control press once again. This time it’s from Hong Kong where residents are returning disposable contact lenses manufactured in Ireland. The product, 1-Day Acuvue TruEye, is being recalled after reports of stinging and pain after insertion of the lenses. J&J has called it “an isolated issue.” It is J&J’s 9th recall this year.
Another UPDATE: The 27 August NY Times reports the recall of J&J subsidiary DePuy’s hip replacement. The article, by Natasha Singer, discusses the quality control headaches that continue to mount at J&J:
“No. 1, is there a systemic issue at J.& J.?” said Rick Wise, an analyst at Leerink Swann, a health care investment bank. “No. 2, is this” hip implant recall “reflective of that systemic issue? And, No. 3, is there more to come?”
In news from GxP Perspectives read the updated article on the Form FDA 1572 in:
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