FDA to supervise three Tylenol plants

March 11, 2011 at 2:01 PM
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WASHINGTON, March 11 (UPI) -- The U.S. government announced it is taking over three Tylenol plants following recalls and a criminal investigation into safety issues at the factories.

The Food and Drug Administration and the Justice Department took action against Tylenol maker McNeil PPC and two of its executives --- its vice president of quality and its vice president of operations for over-the-counter products -- for failing to comply with federally mandated manufacturing practices, CNN reported Friday.

McNeil, a division of Johnson & Johnson, said it had agreed to put the plants under FDA supervision.

The plants are in Las Piedras, Puerto Rico, Fort Washington, Pa., and Lancaster, Pa.

The "consent decree" agreement requires McNeil to adhere to a strict timetable to bring those facilities into compliance.

"This is a strong, but necessary, step to ensure that the products manufactured by this company meet federal standards for quality, safety and purity," Deborah Autor, director of the FDA Office of Compliance, said.

McNeil's drug-making operations have been under intense scrutiny in the past year after successive recalls in 2010 of over-the-counter pain and cold medicines such as Tylenol, Benadryl and Motrin produced at the three facilities.

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