She says so herself.

Johnson & Johnson plans to eliminate 900 jobs at Ortho-McNeil-Janssen unit

That plant manufactured children’s Motrin and Tylenol. McNeil Consumer Healthcare ran the Fort Washington plant for Johnson and Johnson, and they have just laid off 300, or two thirds, or their employees.

From: Department of Health and Human Services: Food and Drug Administration
To: Hakin Erdimer Vice President of Operations, McNeil Consumer Healthcare, Div. of McNeil -PPC Inc. 7050 Camp Hill Road, Fort Washington, PA.

I first became aware of this story earlier this summer when I went to buy some Motrin at my local Happy Harry’s.. I walked up and down the shelves and was perplexed why I didn’t find some. I assumed that Walgreens must be becoming like Walmart and picking the brands they sold based on who could give them the best sweetheart deal. I went to Rite Aide instead. What, they’re out of Motrin too? They don’t even have a tag or slot on their shelves for it. Is there a recall? No one knew of any. After 4 hours, I finally found one bottle, still on the shelf of a chain grocery store, and snatched that baby up. Finally… R E L I E F…

Then I forgot about it… and I saw this….

The FDA has said it is weighing possible civil and criminal action against J&J for its actions. J&J’s CEO Weldon is expected to face sharp questioning over the manufacturing issues and also whether the company had FDA permission to conduct a soft recall of Motrin in 2009 from 4,000 stores across 40 states. It hired a contractor to send out employees posing as buyers for an eight-caplet package sold at convenience stores.Last week, lawyers for J&J said the purchases were legal and that FDA knew about them despite the lack of a formal agreement. But the FDA has said that is not the case. “Right now, there is no independent evidence that showed anybody at the FDA approved it,” said a congressional source familiar with the committee investigation. More documents submitted since the May hearing, including several released on Tuesday, show J&J directed the buyback, the source said, adding that the contractors have also submitted numerous documents.

Why were they buying back their own products? Were they trying to cover something up, or, prevent a mistake from becoming public? Is that the normal method of recalling a product, and if it is not, what was normal procedure not followed in this case?

In January, the FDA identified problems at a Johnson & Johnson plant in Puerto Rico after the company recalled Tylenol, Motrin and Benadryl products made there. The company said a chemical leached from wooden pallets into the products, imparting a musty odor that later made some consumers ill with temporary gastrointestinal problems.

Now I work around pallets all day. They do have a musty oder. But that oder stays in the wood. When I come home and take off my clothes, the same clothes which were in close proximity to those wooden pallets, they have no musty pallet oder. They may smell like BO, but they don’t smell like pallets. And you expect me to believe that tiny little pills inside a glass container, vacuumed sealed with cotton packed on top, surrounded with printed intructions, placed inside individual cardboard cases, which themselves are bundled 48 on a wooden pallet, upon opening,… carry that musty pallet oder in amounts so strong, that it gives consumers temporary gastrointestinal problems? Bullshit.

The human symptoms point to bacteria on the pills. For some reason, the line about the pallets, whether sanctioned by the FDA or not, is a dodge to deflect the true story.

It was the first of four recalls of Johnson & Johnson products in the past year, including the April 30 recall of 136 million bottles of infant and children’s Tylenol, Motrin, Benadryl and Zyrtec. Those products were recalled after FDA inspectors found widespread manufacturing problems at the Johnson & Johnson facility in Fort Washington, Pa., the only plant where they were being made.

In the FDA report, linked above, the closing of the Fort Washington Plant was because the Fort Washington Plant did not ensure….the rejection and withholding from approval any raw material product that contained a “known” contamination of gram negative organisms. Translated: they knew it was contaminated with deadly bacterial organisms and sold it anyway!

Raw material lots had known contamination with gram negative organisms and were approved to use for manufacture of several finished lots of Childrens and Infants Tylenol drug products, which remained within expirations dates on the market.

Translated: Medicine for infants running a fever, with immune systems being down for other reasons, were knowingly and willingly, given a bacterial infection organism known to cause severe gastronomical problems. Is Hakin employed by Al Qaeda? Surely that could be the only reason such a callous act could occur. Or is this the new standard today’s corporate America now upholds?

In fact, Food and Drug Administration inspection reports going back to 2003 chronicle a build up of problems at the now-shuttered plant in Fort Washington, Pa., at the center of the widespread recall of Tylenol, Motrin, Benadryl and other over-the-counter drugs. But it was only after a political change in Washington, that consumer protection stepped up.

Just recently, at an inspection of the Lancaster plant, inspectors wanted to know why some consumers found maximum-strength tablets in regular-strength Pepcid bottles, or mint-flavored tablets in berry-flavor bottles.

The problems were compounded by having to repeatedly ask for documents, and waiting days to receive what should have been readily available, including things as basic as an organizational chart.

Inspectors found that the plant could not ensure that drugs produced there were up to standard. Laboratory controls do not include the establishment of scientifically sound and appropriate test procedures designed to assure that drug products conform to appropriate standards of identity, strength, quality and purity,” the inspectors wrote.

(It should be noted that the newest report does not give any examples of product quality being affected by the litany of carelessness. Nor does it advocate a recall of any of the plant’s products.) What the report does note, is that no one is monitoring the operation. Records that should be accessible at a moments notice, simply aren’t there.

One common theme of the FDA report is that J&J employees frequently took days or weeks to provide records to the FDA inspectors, sometimes despite multiple requests. When the records eventually were provided, they sometimes were wrong or incomplete, the report said. “Organizational charts were requested on 06/23/10 and requested approximately 10 times before receiving full information … on 07/01/10,” read one example.

Another key point of the report was a finding that the plant failed “to thoroughly review” how product quality was affected by equipment problems that occurred during the manufacturing process.

The report tells of cases of “multiple manufacturing deviations” occurring without J&J checking for any impact on the product batches or recording what was done to fix the problems. “There is a failure to thoroughly review any unexplained discrepancy …,” the report said. “Equipment failures were not trended … to determine the scope … and the overall impact on the manufacturing process and products produced.”

The report said J&J displayed a similar lack of vigor in probing the Berry Tablets problem and looking into consumer complaints that products made at the plant were ineffective. The report said a J&J employee used the wrong testing sequence to see how Imodium EZ Chew Tablets dissolve and used the same filter and syringe to take multiple samples of the dissolved tablets. WTF?

Ok that’s the small problem. The big problem is that all corporations are doing the same thing. Why?

Could the previous years of Republican policy of instructing the FDA to turn a blind eye to malpractices in companies that were large Republican donors have anything to do with it? Could the philosophy that businesses need to be freed for endless taxes and bureaucratic red tape be the core of the problem, and not the solution?

The problems were noted as early as 2003 but no action occurred until 2009.

The approach being advocated by Delaware’s Republican Senate Candidate is dangerous to the health and safety of every American. When businesses are not regulated by our government, then we have no knowledge or method to reckon against their harmful acts. In this case, the company was just lazy. They made a conscious decision not to comply with acceptable methods of testing, and assumed no one could hold them accountable for it. In this case, your tax money was used by the Federal Drug Administration to go into a facility, investigate it’s methods, and finding several contamination issues, use it’s authority to close it down. This is a prime example where government is good. This is a prime example of why we need more government, not less. This is what happens when you don’t mind the candy store, which is exactly what Christine O’Donnell is proposing when she says do away with bureaucratic red tape. We need someone minding the candy store. We just need it.

So how does Christine O’Donnell, Republican for Senate, feel this problem should be taken care of? What is the official republican response to having bacterial infectous diseases knowingly placed in bottle of infant Tylenol drops and sold to unsuspecting consumers?

They call for an investigation of the FDA.. No shit. When bacterial contamination known to cause gastro-intestinal problems is knowingly sold to very sick and hospitalized infants… their reaction is to call for an investigation of the FDA…

Chistine O’Donnell says so on her website.

To promote jobs, we need to do away with bureaucratic red tape…… Meanwhile babies die. (But no. … we can’t kill the unborn. Let’s wait till they’re delivered,.. then kill them with bacteria knowingly left in their medicine bottles by one of our big contributors…..)

If we get caught…… we’ll spend a $1000 dollars to pay off a congressman who will then call for an investigation of the FDA ..

So if your reading this, you’re human. Let me ask you,.. how do you want your tax dollar spent? Do you want it spent on someone investigating the actual manufacturing plants to determine whether what’s popped in your mouth is clear of feces and bacterial contamination? Or do you want it spent on investigating the motives of the watchdog organization that is looking after your best interests…?

Christine is wrong on this one… Her Republican Party is out of touch with America and this: the willingness to look the other way when bacterial containments are knowingly put into infant’s medicine, and sold;…. proves it without a doubt.