FDA requests court-ordered action over Tylenol facilities
The Food and Drug Administration and the maker of Children’s Tylenol and other widely used over-the-counter medications have asked a federal judge to sanction a plan to fix manufacturing problems at three of the drug-maker’s plants.
The plan would require McNeil-PPC, a division of Johnson & Johnson, to adhere to a specific timetable to correct violations at the three plants and to hire an independent expert to inspect the facilities and make sure that manufacturing processes meet federal standards. The plants are in Fort Washington, Pa.; Lancaster, Pa.; and Las Piedras, Puerto Rico.
In a statement Thursday, McNeil said a court-approved plan would allow it to focus on bringing its plants into compliance. McNeil closed its Fort Washington plant in April and said it would not reopen until it met quality standards.
FDA inspections at the three plants from 2009 to 2010 found violations of standard manufacturing practices and led to several extensive recalls, including an April recall of millions of units of children’s versions of Tylenol, Motrin, Zyrtec, and Benadryl.
In January 2010, the FDA issued a warning letter to McNeil in connection with violations at the Las Piedras facility. Agency officials have repeatedly criticized the company for being slow to fix problems at its plants.
The FDA filed its request for a consent decree in U.S. District Court in Philadelphia on Thursday.
Deb Autor, director of compliance in the FDA’s drug office, described in a statement the filing as “a strong, but necessary, step to ensure that the products manufactured by this company meet federal standards for quality, safety and purity.”