FDA Takes Over 3 Tylenol Plants

Johnson & Johnson division under scrutiny for manufacturing practices
By Matt Cantor,  Newser Staff
Posted Mar 11, 2011 6:31 AM CST
FDA Takes Over 3 Tylenol Plants
This file photo made June 30, 2009, shows Tylenol Extra Strength in Palo Alto, Calif.   (AP Photo/Paul Sakuma, File)

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.

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. (More Tylenol stories.)

Get the news faster.
Tap to install our app.
Install the Newser News app
in two easy steps:
1. Tap in your navigation bar.
2. Tap to Add to Home Screen.