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Boehringer Ingelheim manufacturing under FDA fire again

This article was originally published in Scrip

Executive Summary

The US FDA has issued a warning letter to Boehringer Ingelheim citing "significant violations" at its manufacturing plant in Ingelheim am Rhein, Germany. It said APIs and drug products from the plant are considered adulterated because of Boehringer Ingelheim's failure to comply with current good manufacturing practice (CGMP), and it highlighted foreign particles found in APIs and a failure to reject or investigate finished products that fell below standard.



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