Tylenol maker pledges quality overhaul

By Parija Kavilanz, senior writer


NEW YORK (CNNMoney.com) -- Drugmaker McNeil Consumer Healthcare, currently under investigation by the Food and Drug Administration following a string of recalls related to its over-the-counter drugs including Tylenol, Motrin and Benadryl, outlined steps Tuesday to remedy serious quality and safety lapses at its manufacturing facilities.

"McNeil is taking steps to bring its operation back to a level of quality that Johnson & Johnson demands of its companies, and that the public rightly expects of us, and that we expect of ourselves," the company said in a statement.

McNeil, a division of Johnson & Johnson (JNJ, Fortune 500), has initiated four recalls of its products in the past seven months, including a widespread recall of children's non-prescription drugs on May 1. Johnson & Johnson has suspended production at McNeil's Fort Washington plant that manufactured the children's products. Johnson & Johnson also faces Congressional hearings on Thursday about McNeil's product recalls.

Among the measures, the drugmaker said it has hired an independent pharmaceutical consulting firm to identify corrective actions to improve quality and manufacturing systems at its Fort Washington facility. The company said it is improving employee training in every part of the manufacturing and quality operations, and implementing new processes for conducting investigations on quality levels.

McNeil also said the company has made significant organizational changes but did not provide details about the changes.

Additionally, the company said it is working with an independent consultant on specific steps to improve overall quality during it what it termed as a "remediation" period, but did not specify its time frame. McNeil also did not say when it would resume production at the Fort Washington plant which makes all of the company's pediatric liquid medications.

During the remediation period, McNeil said it will establish a steering committee of senior management to oversee efforts across the company. Also, each manufacturing facility will also have a remediation committee responsible for implementing the plan for that plant and monitoring its effectiveness.

McNeil said it was enhancing its "good manufacturing practices" training program for all employees and would conduct a full assessment of the processes, equipment, and facility at its Fort Washington and other plants.

Regarding its products, McNeil said it will conduct in-depth quality assessments for each product that the company manufactures to "ensure each product's ability to meet specifications throughout its shelf life."

Further, the company said it will update the FDA about its progress implementing the plan at least once a month and would involve an independent firm in making product decisions during the first six months of operation. Third-party involvement could also include review of investigations, complaints, completed batch records, and changes that have the potential to affect products or processes. the company said. To top of page

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