Healthcare News & Insights

Feds to take over 3 Tylenol plants

After a series of drug recalls and a criminal investigation, the FDA is taking over three manufacturing plants for the popular medication.

The plants, located in Las Piedras, Puerto Rico, Fort Washington, Pennsylvania and Lancaster, Pennsylvania, are run by McNeil Consumer Healthcare, a division of Johnson & Johnson.

Under a consent agreement, McNeil has agreed to put the plants under the FDA’s supervision and meet deadlines for bringing the plants back into compliance with federal safety guidelines. The company also has to hire an independent inspector to certify that the plants have corrected all violations and other issues.

If McNeil violates the agreement, the FDA can order manufacturing at the plants to halt, recall products and levy fines up to $15,000 for each day and an additional $15,000 for each violation of the law — up to $10 million annually.

The plants have had a series of quality problems in the recent past, and questions have been raised over how the company has handled the issue.

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