December 16, 2010

More Problems Found At Johnson & Johnson Plant

Inspectors with the Food and Drug Administration (FDA) have discovered more issues at a Johnson & Johnson plant in Pennsylvania, according to a Reuters report published Wednesday.

An FDA inspection report released late Wednesday evening revealed that a recent visit to the company's Fort Washington plant "uncovered multiple quality control problems, including a failure to properly handle customer complaints," the news agency is reporting.

Furthermore, Reuters quotes the report as finding "a failure to thoroughly review any unexplained discrepancy" in different groups of products, as well as a lack of proper record keeping. The plant has been closed since April, and the inspection took place between October 27 and December 9.

FDA spokesman Christopher Kelly told Reuters that the agency was reviewing the inspectors' findings, and said that they were "not currently in a position to make conclusions regarding their significance."

Meanwhile, in a statement quoted by the news agency, Johnson & Johnson's McNeil Consumer Healthcare unit said that they had been "working diligently to ensure that our manufacturing operations meet the level of quality that consumers and the FDA expect of us," and that the company had "made progress toward that goal" but that it was "an ongoing commitment."

The news is yet another blow in a difficult year for the pharmaceutical company, which has been forced to issue multiple product recalls over the course of 2010. Most recently, the company had to issue a recall for Rolaids Softchews after consumers using the antacids reported finding pieces of wood and metal in the tablets. Additional products recalled by Johnson & Johnson this year include children's Tylenol pain reliever, allergy medication Benadryl, and heartburn medicine Mylanta.

The company is in the process of replacing current chairman and CEO William C. Weldon. According to Natasha Singer of the New York Times, 50-year-old Alex Gorsky and 52-year-old Sheri S. McCoy received promotions to vice chairman and vice chairwoman of the executive committee, effective January 3, 2011. The two, according to Singer, are likely to succeed the 62-year-old Weldon, though no official retirement or resignation has been announced.

"Without question, it signals that the transition process is under way in terms of the era of Bill Weldon ending and setting the stage for a new chairman and chief executive," Rick Wise, an analyst with Leerink Swann, told the New York Times.  "As always"¦ the preference and desire at Johnson & Johnson is to appoint someone who has come up through the system, who has broad experience in various markets and probably has developed an internal constituency that would enable them to lead."


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