FDA Takes Over 3 Tylenol Plants

Johnson & Johnson division under scrutiny for manufacturing practices
By Matt Cantor,  Newser User
Posted Mar 11, 2011 6:31 AM CST

(Newser) – After multiple drug recalls and an FDA safety probe, federal authorities are taking control of three Tylenol plants, CNNMoney reports. The plants, run by Johnson & Johnson’s McNeil division, are in trouble for dodging federal manufacturing rules; now, the company has agreed to let the FDA supervise the three—two in Pennsylvania and one in Puerto Rico—a decision that effectively wards off a threatened FDA lawsuit. The agreement, a so-called "consent decree," is subject to a Pennsylvania judge’s approval.

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Under the consent decree, McNeil must bring the factories to FDA standards according to a timetable. The company is also required to retain an independent expert to certify that problems have been fixed. “This is a strong, but necessary, step to ensure that the products manufactured by this company meet federal standards for quality, safety, and purity,” says an FDA rep. (Read more Tylenol stories.)

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