On April 2, 2026, the U.S. Food and Drug Administration issued a warning letter to Purolea Cosmetics Lab, reference 722591-04022026. By now, most of you have heard the story. The company had used AI agents to write drug product specifications, procedures, and master production records. No qualified person reviewed them. When investigators asked why the firm had distributed product without process validation, the answer was that the AI agent had never mentioned it was required.

The FDA cited 21 CFR 211.22(c) on quality unit responsibility and 21 CFR 211.100 on production and process controls, the clause the FDA reaches for when process validation is missing, and made the point plainly: You can’t delegate compliance to a tool.

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