Tag Archives: FDA

Labels Carry Weight – and Consequences

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It’s not what you say, it’s how you say it. Has a friend ever given you that precious tidbit of information? Ignore it – at least if you work in an FDA regulated industry. The FDA requires pharmaceutical manufacturers to meet exacting standards when it comes to packaging and labeling their products. It’s no surprise [...]

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The Lap-Band: Too Good to be True

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Just in time to fizzle half of the New Year’s Resolutions in Tinsel Town, last month the County of LA requested that the FDA investigate the aggressive marketing campaign behind Allergan’s Lap-Band weight-loss strategy. If you live in Southern California, there is no way that you have escaped the Lap-Band. It’s been featured on most [...]

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Top Ten Tuesday: Worst FDA Recalls of 2010

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2010 was a busy year for the guys and gals at the Food and Drug Administration, with the agency instituting major recalls in several markets. Medical equipment producers, food suppliers and pharmaceutical companies all felt the wrath of the FDA. Even shoddy dog food found itself pulled from the shelves. In no particular order, here [...]

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Ask Why: QC Root Cause Analysis

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Even the best system has glitches. Mistakes do happen. In many cases, isolated non-conformances  aren’t a fatal flaw as long as you can prevent them from happening again. A lot of companies can even unhappily swallow large-scale non-conformances, especially if your quality system is robust enough to identify the problem before defective product ships to [...]

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The Cost of Poor Quality

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The Global Strategic Management Institute recently invited me to begin sharing news and thoughts on FDA-regulated industries and quality control topics. Thinking about this first post, I wondered whether to start things off by rambling on about the importance of quality control or just jump right into recent happenings like Ian Read’s restructuring at Pfizer. [...]

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