Johnson&Johnson, manufacturer of various medical products including children’s Tylenol, reached an agreement with federal regulators from the U.S. Food and Drug Administration Thursday regarding the condition of three of its manufacturing plants. Regulators say that their manufacturing policies do not conform to the law.
According to the New York Times, the agreements were specifically directed to Johnson & Johnson’s McNeil Consumer Healthcare division manufacturing sites situated in Pennsylvania and Puerto Rico. The plants’ policies have been criticized by lawmakers and regulators for over a year now.
“We’ve had a long engagement with McNeil over the last year with regard to their quality system,” Douglas Stearn, an F.D.A. official involved with the agreement said in an interview Thursday.
The agreement concerns a plant in Lancaster, Pa. that makes products in cooperation with Merck, a plant in Las Piedras, P.R. that has already received an agency warning last year, as well as a closed plant in Fort Washington, Pa. Johnson&Johnson was tabooed to reopen the plant until the independent inspector confirms the plants legal compliance.
Once approved by a federal judge, the agreement would require Johnson&Johnson to hire an inspection expert who would monitor and ensure the quality of the manufacturing processes in all three plants. With this F.D.A. would also be given the authority to shut down McNeil once manufacturing flaws were detected, and would be able to fine the company at least $15,000 per day, amounting up to $10 million a year.
Despite the extent of civil complaints covered by the agreement, F.D.A. officials would not comment on related criminal investigations, the New York Times reports. The F.D.A said last year in a Congressional session that the McNeil case was already referred to its office of Criminal Investigations. A spokeswoman confirmed the statement and said that other investigations are underway.
William C. Weldon, Johnson&Johnson’s chief executive, addressed the company’s employees in his statement released Thursday, saying that the company’s higher-ups have been taking care of the manufacturing problems of the specified plants. In spite of praising how the company has already advanced its manufacturing competence, Weldon continued to press the importance of this issue and how measures are being observed to eliminate these problems.
“[The agreement] requires additional quality assurance measures, and is a reminder that important work remains to be done,” Weldon said.