Tuesday, June 23, 2015

Next Time an FDA Inspector Visits, Make Sure Everything is Dusted - Pharmalot - WSJ


Read the full article: Next Time an FDA Inspector Visits, Make Sure Everything is Dusted - Pharmalot - WSJ:

"Records indicated the company supposedly used an oxygen analyzer to obtain test results. But the FDA inspector displayed a Sherlock Holmesian propensity for uncovering discrepancies. The inspector spotted cobwebs running from the portable oxygen analyzer to an adjacent wall, according to the letter. In other words, the analyzer had not been used for, well, a while."

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