Following a slew of recalls that seemed to have pulled just about every Tylenol product from store shelves, three Johnson & Johnson plants responsible for the recalled goods are being put under the supervision of the FDA.
The three plants, all belonging to J&J’s McNeil division, are located in Las Piedras, Puerto Rico, Fort Washington, PA, (about ten miles from my childhood home) and Lancaster, PA.
The consent decree provides McNeil with a timetable to bring the troubled plants 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…
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.
“If McNeil violates the agreement, regulators can shut down the all production at the plants,” a former FDA official explains to CNN regarding the seriousness of the consent decree.
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