Infant formula record and record retention requirements--FDA. Final rule

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    Federal Register
    |November 28, 1991
    PubMed

    Insights

    The Food and Drug Administration (FDA) updates infant formula record regulations. These changes ensure safer, more sanitary infant nutrition through enhanced testing and complaint tracking.

    Area of Science:

    • Food Science
    • Regulatory Affairs
    • Public Health

    Background:

    • The U.S. Food and Drug Administration (FDA) is updating regulations concerning infant formula.
    • This revision is mandated by the 1986 amendments to the Federal Food, Drug, and Cosmetic Act.
    • Current regulations require specific record-keeping for infant formula manufacturing.

    Purpose of the Study:

    • To amend existing infant formula regulations regarding record management.
    • To enhance the safety and sanitary standards of infant nutrition.
    • To ensure compliance with federal mandates for infant formula production.

    Main Methods:

    • Review and amendment of existing FDA regulations.
    • Focus on record-keeping for microbiological testing, nutrient analysis, manufacturer audits, and consumer feedback.
    • Implementation of updated retention policies for critical infant formula data.

    Main Results:

    • Revised regulations specify requirements for record-keeping and retention.
    • Enhanced oversight of microbiological and nutrient testing processes.
    • Improved tracking of manufacturer audits and consumer complaints.

    Conclusions:

    • The updated regulations strengthen the safety and quality control of infant formula.
    • Amended rules contribute to a more reliable and sanitary supply of infant nutrition.
    • These regulatory changes support the FDA's commitment to infant health and safety.

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