Pfizer Warning Letter For Cardboard in Drug Samples
April 10th, 2013 // 2:03 pm @ jmpickett
Exclusive cGMP/FDA News and Compliance
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.
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This is a problem, of course, because the batch sent to the US was contaminated. And, the FDA notes in its March 27 warning letter, that field reports are supposed to be filed to the appropriate agency office within three working days after learning of problems with distributed drug products. Pfizer was not even close – four months elapsed before a report was filed and another four months went by until the FDA actually received the report (HERE IS THE WARNING LETTER).
As is the case in such situations, the FDA warned Pfizer that if the problems are not resolved, shipments of products made at its Wyeth Lederle plant in Catania may be blocked. Mistakes, as you know, happen all the time, but these are sorts of gaffes that the largest drugmakers are supposed to know how to avoid.
The failure to come to grips with basic manufacturing procedures can be a signal to the FDA to look more closely at other facilities in the event there are systemwide issues that need to be inspected. The agency, in fact, has taken such an approach over the last couple of years in reviewing plants run by Novartis, Hospira and Merck KGgA, to name a few
FDA eCopy Webinar – April 10 and May 2
We are holding a very informative FDA eCopy Webinar on both April 10 and May 2 that should help you to answer common questions on how to submit an FDA-compliant eCopy.
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