J&J’s Over-the-Counter Drug Plant Cited by U.S. FDA

Johnson & Johnson, the world’s biggest maker of health-care products, was cited by U.S. regulators over violations at a plant where the company suspended over-the-counter drug production earlier this year.

J&J’s McNeil Consumer Healthcare unit failed to properly track customer complaints and ensure the quality of Tylenol Arthritis Relief, Benadryl Fastmelt Tablets, St. Joseph’s Aspirin and Sudafed PE at its Fort Washington, Pennsylvania, plant, the Food and Drug Administration said in an inspection report released today. FDA staff visited the plant from Oct. 27 to Dec. 9.

Operations in Fort Washington have been suspended since J&J withdrew more than 40 types of children’s pain and allergy medicines on April 30 because of signs of contamination. Members of Congress have investigated J&J’s handling of quality-control issues as product recalls have mounted this year.

“The company has been working diligently to ensure that our manufacturing operations meet the level of quality that consumers and the FDA expect of us, and that we expect of ourselves,” Marc Boston, a spokesman for J&J’s McNeil Consumer Healthcare division, said today in an e-mail.

J&J, based in New Brunswick, New Jersey, said July 20 that the recalls and manufacturing halt would reduce sales by about $600 million this year. The company reported $61.9 billion in revenue in 2009.

Multiple Reviews

The Fort Washington inspection findings are the first released since the FDA identified bacteria in raw materials, dust and equipment in disrepair during an April assessment. Inspectors didn’t issue a notice of violations after a June 18 visit to the facility, according to data obtained by Bloomberg through the Freedom of Information Act.

Most of the issues cited in the recent report involve complaints and data collected before the April recall. The FDA is still reviewing the observations and isn’t in a position “to characterize their significance,” Christopher Kelly, an agency spokesman, said today in an e-mail.

J&J declined 20 cents, or less than 1 percent, to $62.57 at 4 p.m. in New York Stock Exchange composite trading. The company has dropped 2.8 percent this year.

To contact the reporter on this story: Catherine Larkin in Washington at clarkin4@bloomberg.net.

To contact the editor responsible for this story: Reg Gale at rgale5@bloomberg.net.

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