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FDA Warning Letters: August 5

This article was originally published in The Gray Sheet

Executive Summary

R&D Engineering of Earlham Inc. lacks “Quality System procedures and instructions” for the manufacture of suction canisters and lids, and kidney transport trays, FDA says in a warning letter posted online this week. China-based respiratory GaelMed Xiamen Co. is cited for noncompliance to adverse event reporting and quality system rules.

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