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Johnson and Johnson Consumer Health Division United Barred From Resuming Operations in Until Quality Standards are Met-Consent D

Posted Mar 10 2011 6:12pm

The returned product needs to be destroyed the FDA states and in the case of Tylenol, perhaps the folks in Guam could take some of it off their hands to kill snakes <grin>.

The CEO of Johnson and Johnson had this to say to employees:

“I am writing to let you know that one of our companies, McNEIL-PPC, Inc., today will enter into what is known as a “Consent Decree” with the U.S. Food and Drug Administration (FDA). The Consent Decree is an agreement we have reached with the FDA to govern certain McNeil Consumer Healthcare manufacturing operations image until McNeil completes the remediation of its facilities to the FDA’s satisfaction. The Consent Decree is subject to approval by the court.

There are other outstanding legal matters involving Johnson & Johnson companies that have been discussed in past public filings and covered in the media.  We will keep you advised of critical developments in these matters just as we are now providing information about this Consent Decree and McNeil.

We are a company that strives to do the right thing, and we succeed far more often than not. When we don’t succeed, it’s painful. But, consistent with Our Credo, we take responsibility for our actions, and we learn from our mistakes. By moving to resolve the FDA’s concerns about McNeil Consumer Healthcare US manufacturing facilities, we are able to look to the future and focus on what is most important to us: serving the millions of people around the world who rely on our products every day to meet their health care needs.

The Consent Decree applies to manufacturing facilities in Fort Washington, Pennsylvania; Lancaster, Pennsylvania; and Las Piedras, Puerto Rico. Under the terms of the agreement, McNeil will continue to operate the facilities in Las Piedras and Lancaster, working with an independent expert who will develop a plan for improving operations and will conduct reviews of certain production records while remediation is ongoing. McNeil also has agreed that it will not re-open the Fort Washington manufacturing facility – which it voluntarily closed in April 2010 – until it is certified by an outside expert and approval is given by the FDA.

Under its Comprehensive Action Plan, McNeil has made important progress toward improving quality and compliance, such as accelerating changes in organization and culture, and conducting a thorough review of how the company operated its manufacturing plants. We believe the terms of the Consent Decree recognize this progress and are consistent with the work underway. At the same time, the Consent Decree requires additional quality assurance measures, and is a reminder that important work remains to be done. We will commit whatever time and resources are necessary for McNeil to address the issues raised by the Consent Decree.

While the particular issues involved in the Consent Decree are limited to McNeil, all of us across the Johnson & Johnson Family of Companies should take this opportunity to re-dedicate ourselves to working hard every day to do the right thing for patients and ensuring their trust. “

Bar codes and their use sure seem to be looking good and here’s a couple of my past posts referencing this.  They are aware of it too, so it’s a matter of someone taking action and it would make the FDA’s job easier to monitor compliance, so 2 strikes here, one on J and J and the FDA for clumping around without exploring how to better handle such situations.   The FDA has this same bar code suggestion too.

image

Tracking Medical Device Recalls – Sounds Like A Good Place for a Microsoft Tag Data Base at the FDA

There have been requests to establish a UDI for devices and Johnson and Johnson has a few of those going on too so why not solve the entire problem with one solution that is simple and easy for anyone to use.  Just last week the head of their orthopedic division, DePuy left the company too.

As you can read in the letter, an independent expert has been called in to advise and help get them back on track.  BD 

WASHINGTON (AP) -- Federal officials said Thursday that the consumer health unit of Johnson & Johnson will be barred from resuming operations at a Pennsylvania manufacturing plant linked to millions of bottles of defective medicines until it meets quality standards.

The Food and Drug Administration said it signed a formal consent decree with the company designed to improve operations at three manufacturing sites linked to multiple recalls of medications last year, including Children's Tylenol, Benadryl and Motrin.

The FDA said J&J's McNeil Consumer Healthcare unit violated the law in its production of medications and would be subject to fines of up to $10 million annually if it did not comply with the decree.


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