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FDA proposing infant formula CGMP, quality control and reporting requirements.

This article was originally published in The Tan Sheet

Executive Summary

FDA PROPOSED REGS IMPLEMENTING INFANT FORMULA CGMPs and quality control requirements were published in the July 9 Federal Register. The agency is proposing to augment the existing infant formula regs appearing in the Infant Formula Act of 1980 and in 1986 amendments by: establishing requirements for quality factors and current good manufacturing practice (CGMP); amending quality control, notification and reporting requirements; calling for nutrient testing; and requiring that infant formula companies implement the CGMP and quality control standards through their own production control systems.
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