Get Out of FDA’s Crosshairs – Move to Kansas!
March 19, 2013 Want less FDA attention? Consider Kansas. Our recent Webinar on FDA inspections with Dennis Moore, AUK Technical Services, was quite eye opening. Dennis is one of the few consultants that really focuses on the FDA district office level to see what they are up to in terms of writing 483s and warning […]
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Inspection Tip – Please Don’t Put the FDA Investigator in the Boiler Room
March 14, 2013 Â The $100,000 FDA Compliance Disaster Please don’t do this to your FDA investigator. Every time I have Dennis Moore for one of his excellent FDA inspection webinars, I marvel at some of the mistakes that some really bright folks make in the pharmaceutical industry during an inspection.It’s interesting how some of the […]
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Unreported Drug Side Effects Are Found With Internet Searches
March 14, 2013 Don’t Put Your Pharma Company in LA? This is a bit unsettling. According to a recent New York Times article, using search data that was pulled from Google, Yahoo and Microsoft, scientists at Columbia, Stanford and Microsoft were able to find evidence of drug side effects that had not yet been reported. […]
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Ex-Aptuit Employee Busted for Data Scam
How The Quality Manager Gets Fired! A former employee of the Aptuit clinical research organization was found guilty of altering pre-clinical trial data that was used to support applications to perform clinical trials, according to the UK’s Medicines and Healthcare products Regulatory Agency. The MHRA noted this was the first instance in which Good Laboratory […]
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FDA Blasts Company for ‘Liking’ Unapproved Product Claim
How The Quality Manager Gets Fired! Facebook’s “Like†button may not seem like something you really have to think about and commit yourself to before utilizing, but that’s not always the case. FDA wants companies to think twice before throwing the might of their social network behind any statement, even a simple thumbs up. AMARC […]
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Harsher FDA Warning on Pfizer Antibiotic
Avoid a CAPA File Inspection Disaster! FDA increased the strength of the warning for the antibiotic Zithromax, saying there is a small chance the product may trigger a potentially fatal, irregular heart rhythm. Zithromax is a commonly used antibiotic that is also available as a generic drug, azithromycin. The FDA posted a notice on its […]
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Avoid a CAPA File Inspection Disaster
March 18, 2013 We had a very informative webinar with Dennis Moore, AUK Technical Services, this month on surviving an FDA inspection….lots of interesting war and horror stories, things to do and not do. We also have this interesting Webinar coming up on how to design a closed-loop CAPA system. One that was interesting to […]
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How the Quality Manager Gets Fired aka The $100,000 FDA Compliance Mistake
March 12, 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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FDA Warns Stryker on Quality Issues
Orthopedic implant maker Stryker Corp said it received a warning letter from the U.S. Food and Drug Administration related to quality concerns at its Portage, Michigan facility. The letter also said Stryker failed to notify the regulator of a product recall, and had been marketing devices without approval. The FDA acknowledged that Stryker has submitted […]
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Don’t Put Your Pharma Company in LA?
March 14, 2013 The $50,000 FDA Compliance Mistake! One of the most interesting pieces of pharmaceutical-related information we have seen recently is how differently the various FDA district offices behave. There is no doubt about it: Some FDA district offices are more strict than others. For example, in 2011, the LA district office issued 14 […]
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