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Building a Culture of Quality and Compliance: Are 483's Just Part of Doing Business?


Pop quiz!  Where did the following snippets from FDA citations come from? (Winner gets a free coffee mug, runner up gets two -:))

  • Contamination during the manufacture of serum injectables?
  • Failure to measure or account for endotoxins?  
  • Failure to respond to adverse patient reactions?  
  • Presence of vermin and unsanitary conditions at the facility?

From 'On Pharma'

The Ten Best Pharma Quotes of 2011


This year, we introduced our Pharma Replay newsletter, a monthly review of the best quips and quotes coming out of the drug industry. (Subscribe here.) Here’s a look back, in no particular order, at the best quotes of 2011. From these quotes, it appears it was a rough year for J&J, and for jobs.

From 'On Pharma'

Freakonomics Meets the Drug Supply Chain


Counterfeiting, says Johnson & Johnson’s Ron Guido, is a form of flattery. “If you don’t have counterfeits in your business, chances are you don’t have a good brand,” said Guido, J&J’s VP for global brand protection, speaking at the ISPE annual meeting in Dallas last week. In other words, a successful product/brand (Gucci, let's say) is the apple of a counterfeiter's eye.

From 'On Pharma'

Manufacturing Quality Woes for Another J&J Division


Traces of the wood preservative TBA (2,4,6-tribromoanisole) have reportedly been found in batches of the HIV medication Prezista, manufactured by Janssen Cilag, a J&J subsidiary. according to a news report in the U.K. publication, Pink Paper. So far, five batches have been recalled. 
The countries affected include Austria, Canada, Germany, Ireland and the United Kingdom. In the UK only Prezista 400mg is affected.

From 'On Pharma'

Come On Now, Cellulose and Iron Are Good for You


The public and drug regulators have misunderstood J&J's helpful attempts to include supplemental dietary ingredients in its products, forcing the company to recall Rolaids in the U.S. and Canada.

I need my Rolaids. What's wrong with iron filings? The human body needs iron. And there's a helluva lot of fiber in wood, too. Isn't fiber good for you? As to the crystallized sugar, don't it help the medicine go down?

From 'On Pharma'