Comments on: Consent Decree (Finally) for J&J http://blog.pharmtech.com/2011/03/14/consent-decree-finally-for-jj/ The blog of Pharmaceutical Technology magazine Thu, 09 May 2013 23:30:55 -0400 http://wordpress.org/?v=2.8.4 hourly 1 By: Michael Nichols http://blog.pharmtech.com/2011/03/14/consent-decree-finally-for-jj/comment-page-1/#comment-36284 Michael Nichols Thu, 07 Apr 2011 23:00:18 +0000 http://blog.pharmtech.com/?p=3937#comment-36284 Ron, The number of recalls is statistically significant. Walking through the HBA isle of a l0cal Stop & Shop was enlightening. There were three facings for Tylenol PM and 3 facings for Motrin PM. There were no other McNeil products on the shelves. The original 483 for McNeil, Fort Washington, is available on the FDA web-site. Take a read. You will wonder why the consent decree took so long. Dirt on top of stored equipment is not random. It is also of interest that the plant in Lancaster, PA, home of Listerine, which was included in the Pfizer Consumer acquisition got a clean bill of health from the FDA. It was the three McNeil plants that were a mess. Ron,

The number of recalls is statistically significant. Walking through the HBA isle of a l0cal Stop & Shop was enlightening. There were three facings for Tylenol PM and 3 facings for Motrin PM. There were no other McNeil products on the shelves.

The original 483 for McNeil, Fort Washington, is available on the FDA web-site. Take a read. You will wonder why the consent decree took so long. Dirt on top of stored equipment is not random.

It is also of interest that the plant in Lancaster, PA, home of Listerine, which was included in the Pfizer Consumer acquisition got a clean bill of health from the FDA. It was the three McNeil plants that were a mess.

]]> By: Ron Warrick http://blog.pharmtech.com/2011/03/14/consent-decree-finally-for-jj/comment-page-1/#comment-35902 Ron Warrick Thu, 17 Mar 2011 06:43:43 +0000 http://blog.pharmtech.com/?p=3937#comment-35902 Do we really know how JNJ stacks up over the long run, in terms of number of recalls per batch of product produced? They make a lot of products. Are the numbers statistically different from the industry norms? I have yet to see any analysis of this sort. It seems to be assumed that having an unusual number of recalls in a short period is indicative of a trend, but it must also be remembered that "randomness comes in bunches". Do we really know how JNJ stacks up over the long run, in terms of number of recalls per batch of product produced? They make a lot of products. Are the numbers statistically different from the industry norms? I have yet to see any analysis of this sort. It seems to be assumed that having an unusual number of recalls in a short period is indicative of a trend, but it must also be remembered that “randomness comes in bunches”.

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