A drug manufacturer recently gave safety and compliance leaders a preview of a problem that’s going to reach far beyond pharmaceuticals. In April 2026, FDA issued a warning letter to Purolea Cosmetics Lab after inspectors found significant current good manufacturing practice violations. One part of the warning letter has drawn special attention. FDA said the company used AI to create drug product specifications, procedures, and master production or control records, but failed to review those AI-generated documents to ensure they were accurate and compliant. FDA also noted that the company’s overreliance on AI was documented during the inspection. That’s the part every […]