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Animal-Sourced API Requires Impurity Specs Too, FDA Warns Changzhou SPL

This article was originally published in The Gold Sheet

Executive Summary

Even API from complex plant and animal sources must have impurity specifications under the ICH Q7A guidance, FDA tells Changzhou SPL in warning letter. The firm, which supplied Baxter with contaminated heparin API linked to numerous adverse reactions and deaths, should have done a better job testing the heparin and evaluating suppliers, FDA said



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