Pharmaceutial Cargo Thefts on the Rise
Latest FDA and cGMP Compliance News We noted that there was a noticeable drop in the dollar value of pharmaceutical cargo thefts in 2012. Alas, it appears that this was only temporary. Our recent analysis shows that pharmaceutical thieves are having a great year in 2013. To this point, about $3.4 million in thefts have […]
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Another Risperdal Lawsuit Slams J&J
Latest FDA and cGMP Compliance News It seems no matter how much J&J tries to put a stop to lawsuits for the marketing of Risperdal, another suit always pops up. The latest lawsuit involves the attorney general in Kentucky. He, like others before him in the state and federal government, accuse J&J of promoting Risperdal […]
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Serious Drug Recalls On the Rise
Latest FDA and cGMP Compliance News Due to an FDA crackdown on cGMP violations and an increasing shortage of many types of prescription drugs, we are not shocked to learn that we are seeing more FDA drug recalls in the first quarter of 2013. We have seen 107 recalls as of the end of Q1. […]
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FDA Slams Hospira With Another Warning Letter
Latest FDA and cGMP Compliance News Hospira has received another warning letter from FDA, which is the latest in a string of warning letters going back 2 years. The most recent letter is dated May 9 and details about 12 deficiencies in design and quality assurance systems for devices that FDA investigators found during an […]
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How Ranbaxy Tried to Screw FDA
Latest FDA and cGMP Compliance News This week, the US government came to a deal at last with Ranbaxy Laboratories – a cool $500 million fine to settle all criminal and civil charges for serious cGMP violations. The generic manufacturer was charged with making product with raw chemicals from non approved sources, faking in house […]
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Criminal Charges on J&J in South Korea Tylenol Case
Latest FDA and cGMP Compliance News There is a new J&J cGMP manufacturing scandal in South Korea, and it is getting worse. Two weeks after J&J had to stop production on Children’s Tylenol syrup because some bottles had a higher concentration of active ingredient, regulators are bringing criminal charges against people in the Janssen division […]
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More Pharma Jobs Get the Axe
Latest FDA and cGMP Compliance News Layoffs have become quite common in the pharmaceutical industry, and keeping up with all of them can be difficult. Today more jobs have been cut at several pharmaceutical companies. Here is the run down: Purdue Pharma is cutting 90 sales reps who were salesmen for the Intermezzo sleeping drug. […]
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Ranbaxy Production Scandal Costs $500 Million
Latest FDA and cGMP Compliance News After a year when it entered into a consent decree for serious cGMP violations, Ranbaxy Laboratories has now agreed to pay $500 million to settle both criminal and civil issues that were related to the manufacturing problems. The Department of Justice has called this the biggest financial penalty ever […]
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Why Did Senior FDA Official Leave Agency – Congressional Probe
Latest FDA and cGMP Compliance News In May, a top ranking FDA official left the agency – Leone Brenner-Gati for ‘personal reasons.’ She left FDA only seven months after coming on board, after she had a long career at J&J. Now there is a Congressional committee looking into just what she was doing at FDA. […]
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New FDA Warning Letter Shows Web Content Is Extension of Labeling
Latest FDA and cGMP Compliance News FDA this month issued a warning letter for a drug company – Europharma – that has a website that links to articles that has disease claims, which FDA states causes the products to be considered drugs. The company is based in Green Bay, WI, and this warning letter makes […]
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