U.S. Regulators and Johnson & Johnson Unit Reach Plant Oversight Deal

According to The New York Times, federal regulators reached an agreement with a unit of Johnson & Johnson that would impose greater federal oversight at three manufacturing plants responsible for recalls of children’s Tylenol and many other popular over-the-counter medicines. The regulators say that the manufacturing practices failed to comply with federal law. The proposed consent decree with the FDA stems from recurring problems for over a year with products made by Johnson & Johnson’s McNeil Consumer Healthcare division at sites in Pennsylvania and Puerto Rico. Lawmakers and regulators have repeatedly criticized the company for its inability to manage production at these plants. Under the agreement, which needs approval from a federal judge, Johnson & Johnson would be required to hire an independent expert to determine whether operations at all three plants met federal standards and to ensure that quality systems were in place. The agreement covers a plant in Fort Washington, Pa., that the company closed last year for an overhaul amid a nationwide recall of children’s medicines; a plant in Las Piedras, P.R., that was the subject of an agency warning letter last year; and a plant in Lancaster, Pa., that makes products like Pepcid for a joint venture with Merck. McNeil cannot reopen the Fort Washington plant until an independent expert determines that the plant meets all federal standards and passes an agency inspection, according to the agreement.