When you peel back the layers of causes leading to serious FDA enforcement action, it comes down to a handful of fundamental reasons.

1. Management doesn’t know what is required

Executive and senior management might not have regulatory experience. MBA programs may offer courses on quality, but usually they are more about the popular concepts of lean manufacturing, not the Federal Food, Drug, and Cosmetic Act or the Code of Federal Regulations and current good manufacturing practices (CGMPs). Some executives may go so far as to think that if their companies are doing Six Sigma, they have a quality program.

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