J&J charged with US manufacturing violations
pharmafile | March 15, 2011 | News story | Manufacturing and Production | J&J, JJ, Johnson and Johnson, McNeil Consumer Healthcare, McNeil Fort Washington, McNeil recall, Motrin recall, manufacturing compliance, pharma manufacturing, recalls
Johnson & Johnson subsidiary McNeil Consumer Healthcare has been officially charged with manufacturing and distributing drugs in violation of federal law, along with two senior executives.
The company has been placed under a consent decree by the FDA and US Justice Department, a legal measure which requires McNeil to adhere to a strict timetable in bringing its manufacturing operations back up to standard.
J&J has had to undertake a string of product recalls affecting millions of over-the-counter medicines in 2009 and 2010 because of quality control issues at plants in Fort Washington and Lancaster in Philadelphia, and Las Piedras in Puerto Rico.
The decree prevents McNeil from manufacturing and distributing drugs at its Fort Washington plant – which is already closed and is not expected to reopen anytime soon – and orders the firm to destroy all medicines recalled from the three failing plants since December 2009. The Lancaster and Las Piedras plants can remain open, says the decree.
Name-checked in the charges are McNeil’s vice president for quality Veronica Cruz and vice president of operations/OTC products Hakan Erdemir.
J&J will be under regulatory scrutiny for at least five years as a result of the action. The company must also appoint an independent expert to inspect the three facilities and determine whether the violations have been corrected and GMP standards are being maintained.
If the defendants violate the decree, the FDA may order McNeil to cease manufacturing, recall products, and take other corrective action, including levying fines of $15,000 for each day and an additional $15,000 for each violation of the law, up to $10 million annually.
J&J seems to have got off remarkably lightly, given the scale of its manufacturing problems and the number of recalls.
Another drugmaker which has been struggling with manufacturing quality problems, US biotech Genzyme, ended up paying more than $175 million in fines last year under the terms of a consent decree affecting its facility in Allston Landing, USA.
“This is a strong, but necessary, step to ensure that the products manufactured by this company meet federal standards for quality, safety and purity”, commented Deborah Autor, director of the FDA’s Office of Compliance.
J&J is still facing investigations by the US Attorney’s Office and Congress into its failure to maintain standards in its manufacturing plants, as well as other issues such as the ‘phantom recall’ of Motrin, in which the company bought back stocks of the medicine using mystery shoppers in order to avoid announcing a recall.
Phil Taylor
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