Checking in on FDA enforcement stats

摘要

Reading the U.S. Food and Drug Administration's enforcement statistics is like reading tea leaves, with all due respect to tea leaf readers. It's generally the case that examining the numbers of FDA inspections, Warning Letters, seizures, injunctions, prosecutions, import refusals, and recalls can leave one confused about whether the consumer protection agency is being busy or sleepy, aggressive or lax.rnIt's also the case, admittedly, that for any individual packager in an FDA-regulated business (food, drug, medical device, cosmetic, animal food and drug, biological products, radiological products), the statistics are just about meaningless if your company is the subject of a particular enforcement action. Still, it can be useful to put your particular issues into some context, and that is the goal of examining these statistics.