Kremlin on the Schuylkill: McNeil To Gut Contaminated Plant
| Kremlin on the Schuylkill: McNeil To Gut Contaminated Plant |
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| July 16, 2010 by Donald Riker, PhD |
Article
After months of furtive recalls J&J released an outline of a plan submitted to the FDA to fix the collapse of its quality control systems governing its OTC products. As predicted by OTC Product News in a series of editorials filed as early as December, 2009 the fixes hint at major organizational changes, process improvement, use of outside experts, and rebuilding of plant & equipment. J&J will transfer manufacturing to other plants not affected by the outage (which ones are not identified) but still won't be able to build inventory until year end. One pregnant question unanswered in the press is whether the quality system SOP's, reporting relationships, and systems are truly restricted to one division of the J&J corporate hierarchy. Quality regulations make little distinction between Rx and OTC products. Early in this evolving story J&J's medical device division received a stern warning letter related to its sterilization devices failures, for example. In trying to contain the PR damage of the Tylenol mess no one has seen fit to assure doctors, third-party payers, or patients as to whether the quality systems governing prescription drug handling and manufacture are subsumed by the same broken system. Does anyone care about the quality of J&J's Rx products? To paraphrase a Financial Times reporter's recent quizzical metaphor: "If this is a contagion is it spread by sharing needles?"
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In a hard-to-find, unsigned statement McNeil, not "J&J", issued a Kremlinesque announcement of job lay-offs of 75% of standing headcount and an extended shut-down at its Fort Washington plant lasting into 2011 following its plant contamination and cavalier management. The fact that this statement was not issued as a corporate press release on its websites confirms more "skulking on the Schuylkill".Sign up for our Email Alerts
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