Once again, Ed Silverman from the Pharma industry blog, Pharmalot seems to have the story on the continuing saga regarding Johnson & Johnson and the massive recalls from their McNeil Consumer Group.
In his blog Mr. Silverman provides some insight into some reports from CNN including video on their report.
According to Pharmalot:
· The recent rash of recalls, which has sullied the storied Johnson & Johnson image, actually reflects a series of production gaffes that go back several years, according to a report from CNN, which collected various FDA inspection reports by filing with Freedom of Information Act requests.
· The healthcare giant actually committed several violations that were detailed in inspection reports. Of course, companies with extensive manufacturing operations are likely to commit errors now and then, but the point CNN tries to make is that a pattern appears to exist.
· A December 2003 inspection report noted a mislabeling problem related to some lots of children’s soft-chew Tylenol; packages listed an incorrect amount of an ingredient per tablet. McNeil did not recall the affected products but destroyed and relabeled the products that had not yet been released into the market. In January 2006, FDA inspectors noted some equipment used to make drugs had not been properly cleaned. Another report from February 2008 listed insufficient follow-up and investigation of consumer complaints.
· The healthcare giant actually committed several violations that were detailed in inspection reports. Of course, companies with extensive manufacturing operations are likely to commit errors now and then, but the point CNN tries to make is that a pattern appears to exist.
· A December 2003 inspection report noted a mislabeling problem related to some lots of children’s soft-chew Tylenol; packages listed an incorrect amount of an ingredient per tablet. McNeil did not recall the affected products but destroyed and relabeled the products that had not yet been released into the market. In January 2006, FDA inspectors noted some equipment used to make drugs had not been properly cleaned. Another report from February 2008 listed insufficient follow-up and investigation of consumer complaints.
Clearly it would appear that there is a lot of past and present history that will be sorted out over the next several months as a variety of regulatory bodies, including Congress put Johnson & Johnson through their paces.
Secure Pharma Chain Blog, encourages everyone within the pharmaceutical supply chain, from manufacturer to dispenser, to deploy authentication technologies to protect their brand, inventories and the consumer from poor quality, fraud, adulteration and counterfeiting .
To read this excellent Pharmalot blog, visit: http://www.pharmalot.com/2010/06/johnson-johnson-was-a-repeat-offender/.
To learn more about pharmaceutical supply chain authentication solutions, visit: http://www.xstreamsystems.net/.
Posts
No comments:
Post a Comment