NEW YORK – The government is taking over three Tylenol plants following a blizzard of drug recalls and a Food and Drug Administration criminal investigation into safety issues at the factories.
The FDA and the Justice Department took action yesterday against 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 practice.
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McNeil, a division of Johnson & Johnson said it had agreed to put its plants — one in Las Piedras, Puerto Rico, one in Fort Washington, Pa. and one in Lancaster, Pa., under FDA supervision.
The agreement, known as a “consent decree,” is subject to approval by a federal judge in Pennsylvania.
The decree requires McNeil to adhere to a strict timetable to bring those facilities into compliance.
McNeil also must retain an independent expert to inspect the three plants to determine whether the violations have been corrected, and to ensure that adequate manufacturing processes are in place. After expert certification, the FDA will determine if the facilities are in 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,” said Deborah Autor, director of the Office of Compliance with the FDA.
If McNeil and the executives violate the decree, the FDA may order McNeil to cease manufacturing, recall products, and take other corrective action, including levying fines of $15,000 for each day and an additional $15,000 for each violation of the law.
The fines can total up to $10 million annually. (CNN)
