Drug Maker Cited on Quality Issues

[SecularMotion]

Source: NY Times

Months after McNeil Consumer Healthcare, a unit of Johnson & Johnson, recalled millions of bottles of Tylenol and other over-the-counter drugs, the division is still plagued with manufacturing flaws, according to the Food and Drug Administration.

Agency officials who filed an inspection report, posted on the agency’s Web site this month, about a McNeil plant in Puerto Rico cited a variety of problems: distribution of drugs that failed quality requirements, a failure to identify product defects during routine testing, failure to detect incorrect expiration dates on drug labels, failure to adequately investigate product problems, failure to follow laboratory controls and inadequate training of lab staff.

Last January, the agency sent a warning letter to Peter Luther, the president of McNeil, about significant manufacturing violations at the same plant. The new inspection report indicates that some problems have not been corrected, said Karen Riley, a spokeswoman for the F.D.A.

“Clearly, this inspection shows that the company continues to have serious quality control issues at its plant and that it is not in compliance with current good manufacturing practices required by federal law,” Ms. Riley said Friday. The agency, she added, was not aware of any harm to consumers associated with the latest problems at that plant.

Read more: http://www.nytimes.com/2010/11/27/business/27drug.html?_r=1&hp

[Mimosa]

1. After all, we can't have medicines made in the USA

I'm scared that some of my RXs were made in China.

[trud]

3. china

Me too. How crazy is it having an essential healthcare product made in China.

When I was growing up, Johnson & Johnson was good people. How the mighty have decayed.

[54anickel]

4. Justs to "put you mind at ease", J&J had problems at the Fort Washington, PA plant as well

So, its not just an outsourcing "thang".

[Dappleganger]

5. Quite true, however...

what I have noticed is that problems which occur within a US manufacturing plant are usually detected and corrected far more quickly than when they're in Puerto Rico, Ireland or another country. Also, the number of incidences regarding manufacturing issues are quite a bit higher at the non-US plants due to non-compliance with the original manufacturing specifications. IOW, the incidences occurring within the US pale in comparison to those outside the US--not nearly the degree of control there.

I know this because until recently my husband worked for J&J in manufacturing (both machinery and processes) for nearly a decade.

[dballance]

2. Oh, And Bringing Cheap Meds Over the Border from Canada is Bad?

So just another lie put to rest. The FDA and the big Pharma companies don't provide us with safe drugs. That whole argument about it being dangerous and the quality being bad when people buy cheap drugs from outside the US is obviously BS. It's obvious the "approved" drugs we get from overseas manufacturing are not really safe at all.

So why do we allow these jerks to keep raping us for medicines?