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Between conflicting guidance, evolving ingredient definitions (particularly around ultra-processed foods) and increased scrutiny, companies are navigating the uncertainty around whether todays reformulation investments and priorities will still be compliant tomorrow
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Case Studies and Real-World Examples While the Purolea case is the first of its kind for drug GMP, similar issues have arisen elsewhere in life sciences: Exer Labs (Device) As noted, the February 2025 FDA warning letter to Exer Labs concerning its AI diagnostic scanner provides a complementary lesson
