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AI & CGMP: FDA's 1st Warning Letter on Non-Compliant AI in Manufacturing
April 23, 2026

The FDA’s April 2026 Warning Letter to Purolea Cosmetics Lab is a notable milestone for the pharmaceutical industry. Whi...

Warning Letter Roundup - January 2017
January 12, 2017

The FDA sends Warning Letters and 483s to companies who significantly violate FDA regulations. We gather those related t...

Warning Letter Roundup - December 2016
December 19, 2016

The FDA sends Warning Letters and 483s to companies that significantly violate FDA regulations. We gather those related ...