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Johnson & Johnson Unit Signs Consent Decree With F.D.A. 2011-03-11
By REED ABELSON

Johnson & Johnson Unit Signs Consent Decree With F.D.A.

The McNeil Consumer Healthcare Division of Johnson and Johnson, which has been besieged by manufacturing problems and recalls of children’s Tylenol and other over-the-counter medicines for more than a year, reached a consent decree with the Food and Drug Administration on Thursday.

The decree focuses on three manufacturing plants that have been highlighted for problems and recalls in recent months. Two of them are in Pennsylvania, and McNeil has already closed one until it can be overhauled. The third plant is in Puerto Rico. (In January, The Times published a lengthy article on problems with McNeil and J.&J. products. )

The decree also formalizes oversight by an independent expert to ensure that the plants are brought into compliance with federal standards. No fines were announced with the decree.

The F.D.A.’s news release can be found here, and McNeil also issued its own release.


 
 
 
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