May 5, 2010

FDA: Bacteria Found In Johnson & Johnson Plant

A report released by the Food and Drug Administration (FDA) on Tuesday said inspectors found thick dust and grime covering specific equipment that may have contaminated dozens of products produced at a Johnson & Johnson plant.

After the company issued a voluntary recall last week on Children's Tylenol and other products labeled for children, the FDA sent inspectors to investigate the possible cause of the recall. Inspectors also found a hole in the ceiling and duct tape-covered pipes at the Fort Washington, PA plant.

Inspectors also found raw ingredients contaminated by an unspecified bacteria, a lack of quality control procedures and poor handling of complaints, according to a report from April 30.

The FDA is now urging parents to choose alternative medicines or generics for their children.

"Consumers should not use these products," said Deborah Autor, director of the Office of Compliance at FDA's Center for Drug Evaluation and Research, in a conference call with Reuters.

According to the report, inspectors found 46 consumer complaints about dark material found in liquid products between June 2009 and April 2010. J&J said on Tuesday that the quality issues at the plant "are unacceptable" and that it would continue to work with the FDA to solve them.

The company has halted production at the Fort Washington plant until further notice. "We will not restart operations until we have taken the necessary corrective actions and can assure the quality of products made there," said a statement from J&J's McNeil Consumer Healthcare unit.

The McNeil Consumer Healthcare unit has said some of the recalled medicines may have a higher concentration of the active ingredient than listed on the bottle. Others may contain particles, while others may contain inactive ingredients that do not meet testing requirements.

The recall is seen as a minor financial concern for J&J, according to investors. While the Tylenol brand is closely tied in with its public image, it amounts for just a small percentage of the company's $62 billion in annual sales.

The FDA has vowed to keep better industry oversight under the Obama administration. The recall has shown that companies need to be more responsible to ensure the quality of their products.

"While the potential for serious health problems is remote, Americans deserve medications that meet FDA standards for quality, safety and efficacy," FDA Commissioner Margaret Hamburg told reporters.

The FDA inspectors found contaminated raw materials used in several lots of Children's and Infant's Tylenol, however none of the finished product sampled tested positive.

Inspectors plan to make a more detailed report for FDA officials to evaluate and determine if further regulatory action is needed, said Autor. It could include sending a warning letter, seizing material and products, seeking a court order to shut down manufacturing or pursuing criminal allegations and penalties.

J&J endured a massive recall in the 1980s of its intentionally contaminated Tylenol products and its subsequent handling of the case is widely studied as a model business and public relations case.

The company has so far done everything right in handling the latest recall, according to branding expert Robert Passikoff. "There's no way to excuse it and J&J isn't. What they're looking to do is fix whatever the problems are," said Passikoff, head of Brand Keys Inc.


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