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FDA Details Multiple Violations at Another Johnson & Johnson Plant

Jul 22, 2010 | Parker Waichman LLP

Federal inspectors found multiple violations at a Johnson & Johnson facility near Lancaster, PA that makes over-the-counter products like Mylanta, Pepcid and Imodium. According to the Associated Press, the Food & Drug Administration (FDA) said the violations could affect the quality and makeup of the drugs.

We reported earlier this week that the facility, which is part of Johnson & Johnson-Merck Consumer Pharmaceuticals, had recently been issued a “Form 483″ by FDA inspectors. Such a form is issued after an FDA inspection yields unsatisfactory results for compliance with regulations or a violation of good manufacturing practices. If a company does not adequately address the deficiencies cited in a such a report, the FDA can issue another one or escalate its response to a warning letter. Failure to correct violations can result in fines or even tougher measures by the FDA.

According to the Associated Press, the violations uncovered by FDA inspectors indicate “a pattern of ignoring rules for manufacturing and quality, failure to investigate problems that could affect the composition of products, carelessness in cleaning and maintaining equipment, and shoddy record-keeping.” The violations cited in the report included medicine batches made during equipment failures that were not checked for quality.

During their visit in April, FDA inspectors had to ask for information many times in some cases, and then wait days to get it, the Associated Press said.

FDA spokeswoman Elaine Gansz Bobo told the Associated Press that the agency is still working on its final report on the Lancaster plant, and has not yet determined what its next steps might be.

Johnson & Johnson has been under scrutiny since April, when its McNeil Consumer Healthcare unit recalled more than 40 varieties of children’s Tylenol and other medicines. That recall was just one of six McNeil has issued for its cold and pain relief products over the past year.

That same month, FDA inspectors cited more than 20 manufacturing problems at the Fort Washington facility where the recalled drugs were made. McNeil has since shut the Fort Washington facility to address the manufacturing problems cited by the FDA. The plant is expected to stay closed well into next year, and 75 percent of its workforce has been laid off.

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