The U.S. Food and Drug Administration’s April 2, 2026, warning letter to Purolea Cosmetics Lab is making the rounds, mostly under some version of “FDA cracks down on AI in manufacturing.”

That’s the wrong way to read this. If you build medical devices, treating this issue as an AI story will cause you to miss the part that actually applies to you.

Purolea wasn’t a story about AI gone wrong. It was a story about a company with no functioning quality unit trying to use AI to fill the gap. The AI didn’t fail Purolea. There was nothing for it to plug into.

What actually happened

If you strip the AI angle out, the FDA’s findings read like any inspector’s worst-day list: insects and filth in the manufacturing area; unapproved homeopathic drugs labeled to treat shingles and genital herpes; no microbiological testing of finished product; no identity or purity testing of incoming components; no process validation before distribution; a quality unit that didn’t establish procedures, didn’t review batch records, didn’t implement production controls...

These are the real problems. Everything in the letter about AI is downstream of them.

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