The U.S. Food and Drug Administration, troubled by a series of drug recalls by Johnson & Johnson in the 18 months, has closed the company's plant in Fort Washington, Pennsylvania, until J&J can show improvements in its manufacturing procedures. The drug maker has pledged to clean up the Fort Washington plant as well as two other plants at the center of the FDA's investigation.
The plant closure is part of a formal consent decree agreed to by J&J that is meant to improve operations at the plants. Besides the Fort Washington location, the other plants affected are in Lancaster, Pennsylvania, and Las Piedras, Puerto Rico. The plants have been linked to multiple recalls of popular over-the-counter medications such as Children's Tylenol, Benadryl and Motrin, according to the Philadelphia Inquirer.
The agreement, which was filed in U.S. District Court in Philadelphia, requires J&J to destroy all defective drugs returned to the company within 30 days, and sets strict dates for third-party inspectors to look over the plants to come up with recommendations for improvements. The Lancaster and Las Piedras plants will remain open during the process.
The Fort Washington plant actually ceased production in April. It will not reopen until both a third party inspector and the FDA certify that conditions have improved enough to resume making drugs there. The company does not expect that to happen until the end of 2011 at the earliest.
The agreement is fallout from a troubled period in the medical product giant's history. J&J and its business unit McNeil Consumer Healthcare, which ran the plants, have issued 20 drug recalls since September 2009. Besides Children's Tylenol and other medications, the recalls have involved contact lenses and DePuy ASR artificial hips.
Source: The Philadelphia Inquirer, "FDA cracks down on J&J sites linked to recalls," Matthew Perrone, March 11, 2011




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