Mold – Another Compounding Pharmacy Recall
Avoid Warning Letter Disasters With a Strong Quality Agreement In the latest fallout from the compounding pharmacy scandal, a compounder has recalled all of its nearly 100 products after a Connecticut hospital noticed “visible particulate contaminants†that turned out to be mold in 50 millimeter bags of an intravenous solution. The move was disclosed on […]
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FDA Drops Hammer on ‘Latex Free’ Claim
March 18, 2013 The claim “latex-free” is impossible to guarantee and should not be used on labeling of medical products, according to new guidance from the U.S. Food and Drug Administration. “FDA is aware of no test method or combination of test methods available at this time that can demonstrate the absence of proteins or […]
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About that 15 Day Response Time for FDA 483s? FDA Means It!
March, 18, 2013 It always amazes me. The pharmaceutical industry is full of some of the brightest and most dedicated professionals in any industry anywhere. However, some of the simplest FDA regulations can trip up some very smart people at some very big companies. The biggest example I can think of is one that our […]
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Like Candy at Easter – FDA Hands Out CAPA 483 Observations
Latest FDA and cGMP Compliance News Avoid a CAPA Inspection Disaster With a Closed Loop, FDA Compliant CAPA System, and Learn 7 Powerful Tools for Root Cause Analysis In the recent past, it seems that FDA has thought that if it focused a great deal on CAPA, it would solve many of the problems in […]
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Industry Bafflement by CDRH eCopy Rule Continues; FDA Confused, As Well
March 18, 2013 You probably know by now that CDRH now requires eCopy for most submissions since Jan. 1, 2013. Our electronics submissions expert, Antoinette Azevedo, has been informing us of some of the chaos that surrounds the new requirement both in the industry and at FDA (see our post on eCopy last week). As […]
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KV Pharma Attacks FDA – Again!
How the Quality Manager Gets Canned If at first you don’t succeed… KV Pharmaceutical is not giving up in its fight with the FDA. The embattled drugmaker is appealing the dismissal last fall of a lawsuit that claimed the agency abdicated its responsibility to prevent some compounding pharmacies from offering lower-cost versions of its controversial […]
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Teva Pays Big Bucks for Wrecking Environment
How the Quality Manager Gets Canned As increasing concern mounts over the extent to which pharmaceuticals may harm the water supply, drugmakers are being scrutinized quite closely for infractions that contribute to the problem. The latest instance involves Teva Pharmaceuticals, which agreed to pay $2.3 million to resolve a series of violations at a Missouri […]
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Why Is CDRH’s eCopy Confusing Everybody?
March 15, 2013 Avoid the CDRH eCopy Chaos! CDRH now requires eCopy for every submission since Jan. 1. According to electronic submissions expert Antoinette Azevedo, there have been instances of many eCopy holds at CDRH because of so many issues with the new format of eCopy. A hold means a delay, which means loss of […]
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FDA Chief of Generic Drugs Hits Exit After Only 8 Months
March 14, 2013 After just eight months at the FDA, Greg Geba is leaving his job as director of the Office of Generic Drugs over differences that emerged following a recent reorganization. His departure, which takes effect on Friday, comes at an inauspicious moment because the FDA, for the first time, recently began collecting user […]
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No New Boats This Year for J&J Execs – Big Pay Cuts
March 14, 2013 Citing various ‘disappointments’ and a ‘mixed’ overall performance, Johnson & Johnson lowered the bonuses given to ceo Alex Gorsky and other top execs by 10 percent. The move comes after three years of scandals, manufacturing gaffes, an FDA consent decree, shareholder lawsuits and, in particular, criticism that the compensation given to Gorksy’s […]
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