U.S. Government Takes Control of Tylenol Manufacturing Facilities
What? GM not working out for ya’?
Yup, this is the type of stuff communist countries do all the time. Apparently, the consumer system of quality control—i.e. – if Tylenol is killing people, then people stop buying Tylenol—and the free market system isn’t good enough for fascists; they feel it’s necessary to step in at the drop of a hat to ensure everyone respects their authori-t-a-a-y:
U.S. takes over three Tylenol plants
By Parija Kavilanz, senior writerMarch 11, 2011
NEW YORK (CNNMoney) — 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 on Thursday took action 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.
McNeil, a division of Johnson & Johnson (JNJ, Fortune 500), 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.
Hm… Just who pockets all that money, I wonder? Anyone want to take a stab at it?
While a consent decree isn’t an unprecedented step, that action is also not taken frequently, said Douglas Stearn, assistant director with FDA’s Office of Compliance.
“It is a significant step,” he said.
The agreement also requires McNeil to destroy all drugs under its control that have been recalled from the three facilities since December 2009.
Stearn declined to comment on the Justice Department’s ongoing criminal investigation into McNeil’s recall activities.
David Rosen, a former FDA official, called Thursday’s developments “very serious” for McNeil and its parent Johnson & Johnson.
“If McNeil violates the agreement, regulators can shut down all the production at the plants,” said Rosen.
Consent decrees are also very expensive for companies, he said. “McNeil will have to pay for the outside expert and the new inspections. And there’s millions of dollars in lost sales from drug products that can’t be marketed.”
Millions of dollars you, the consumer, will ultimately pay for.Explore posts in the same categories: Abuse of Power, politics