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[March 2025] In-Process Testing Guidance, 2024 Device Recall Analysis + Pharma Supply Chain Warning Letters

We break down new FDA guidance on batch uniformity and in-process controls, examine the hidden patterns behind 2024's medical device recalls, and dissect warning letters issued to API suppliers.

Originally published March 2025.

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In this month’s analysis, we examine FDA guidance on in-process testing for pharmaceutical manufacturers, analyze the pattern of medical device recalls that defined 2024, and dissect four recent warning letters that reveal persistent vulnerabilities across the global pharmaceutical supply chain.

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