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Another Johnson & Johnson Facility Found Lacking

Jul 19, 2010 | Parker Waichman LLP

Another manufacturing facility operated by a Johnson & Johnson concern has been cited by federal regulators for substandard manufacturing practices. This time, it’s a facility in Lancaster, PA that Johnson & Johnson shares with Merck & Co. The facility, a part of Johnson & Johnson-Merck Consumer Pharmaceuticals, makes non-prescription products like Mylanta, Pepcid and Imodium.

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.

McNeil has since shut the Fort Washington, PA facility that made those drugs to address manufacturing problems cited by a Food & Drug Administration (FDA). The plant is expected to stay closed well into next year, and 75 percent of its workforce has been laid off.

According to CNN, FDA inspectors apparently didn’t like what they found at the Lancaster facility, and issued it a “Form 483″. Form 483 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, CNN said. Failure to correct violations can result in fines or even tougher measures by the FDA.

One industry expert told CNN that the report is bad news for Johnson & Johnson. “It shows that there is a systemic issue at the company and management has to do a better job in bringing the facilities into compliance with FDA regulations,” Bill Kurani, founder of Antrix Inc., a regulatory affairs & quality assurance consulting firm, said.

While the FDA wouldn’t comment on the report, Johnson & Johnson did confirm that the company has received a Form 483 relating to the Lancaster operation.


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