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Difficulty Identifying Experts Seen as a Factor in Poor Investigations

This article was originally published in The Gold Sheet

Executive Summary

Pharmaceutical enterprises have become so complex that some sites with quality problems can’t find the root cause because they no longer know who their key experts are or where to find them, one industry expert says. Regardless of why they happen, inadequate investigations continue to be the most frequently cited GMP concern in FDA warning letters year after year.

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