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Posts Tagged ‘FDA Warning Letter’

Don’t Let Your Investigators Ruin Your Study By Doing This

I enjoy reading FDA Warning Letters. They’re insightful and often entertaining. Sometimes, though, they’re kind of unbelievable. And, sometimes, they’re downright nauseating. Take, for example, this letter issued on February 19, 2016 to a principal investigator (PI) based in New York. FDA inspectors found him to be in violation of 21 CFR Part 312.62(b), related […]

Were Kim Kardashian’s Instagram Posts Worth It?

Since the infamous Kim Kardashian Instagram post went up and the FDA issued a Warning Letter to Duchesnay, the company she was representing, a couple of things have happened. For one, Kim has issued a corrective post (i.e., ad), which outlined the safety information for Diclegis, the medication for morning sickness she is promoting. And, […]

FDA Warning Letter Trends Show That Medical Device Companies Need To Improve These 3 Things

U.S.-based Medical Device companies, take note: Between October 1 and December 23, 2014, the FDA issued 11 FDA Warning Letters to your peers. With an average of almost one per week, it’s clear that medical device companies are BIG on the FDA’s radar right now. While the Letters touch on nearly every aspect of the […]

This Recent FDA Warning Letter Shows You Exactly Why Quality Matters

“Quality, quality, quality.” You hear it all the time from your QA colleagues. There are so many forms to fill out, trainings to complete, procedures to read and follow, and internal audits to produce records for. Sometimes, it’s so overwhelming that we’re tempted to just tune it out. That is, until we read an FDA Warning […]