Day

May 20, 2026
20
May

A new warning about unchecked use of AI in the quality process

May 20, 2026
An FDA warning letter to a pharmaceutical manufacturer cites non-compliant use of AI use in manufacturer quality systems. It is also a warning about using AI in medical device manufacturing outside the typical algorithm and machine learning applications. The FDA sent a warning letter to Purolea Cosmetics Lab on April 2, 2026. The part about...
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