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Waiter, There's Cardboard in My Sample: FDA Warns Pfizer Inc. (PFE) Over Manufacturing Gaffes


4/11/2013 8:19:17 AM

In its latest bid to clamp down on wayward drug manufacturing, the FDA cited a Pfizer plant in Italy for violating some fairly basic procedures. The first involved problems with testing samples of batches of a diluting agent for its Torisel kidney cancer drug and claiming false positives were caused by interference from cardboard packaging. Yes, cardboard. The drugmaker, however, failed to offer any "credible explanation" as to how cardboard may have made its way into the samples. The other snafu was a failure to file field reports after learning of bacterial contamination. Specifically, the Catania, Italy, plant reported on April 17, 2012, that endotoxin results had been found on January 4, 2012, but the FDA did not receive a report until August 9, 2012. Meanwhile, a batch of the Torisel diluting agent had been shipped on January 5, 2012, to a packaging facility, which then shipped vials of the batch to the US on April 3, 2012.

Read at PharmaLive

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