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  • FDA Cosmetics Factory Inspection

    What is the basis of the FDA cosmetics factory inspection?


    As a global technical service provider that is professional in the field of medical device regulations, SUNGO can provide the following services:

         1.  Analyze the gap between the existing QMS and regulatory requirements

         2.  Collect the existing documents; the counselor and the relevant personnel of the enterprise correct the document system jointly;

         3.  Identify and correct the defects of workshops and warehouses; provide the audit skill training for the relevant personnel of the enterprise;

        4.   Arrange our auditor to conduct a simulated audit;

        5.   Accompany the FDA factory inspection and serve as a translator;

        6.   Assist the enterprise to correct the nonconforming items.

    SUNGO service process



    Specific task

    Division of work



    Establishing and improving the system meeting the Cosmetic GMP

    Both parties

    2-4 weeks


    Identifying the differences between the enterprise’s current system and the Cosmetic GMP and proposing the rectification suggestions

    Both parties

    1-2 weeks


    Inspecting the rectification of the differences

    Both parties

    1-2 weeks


    Serving as the accompanying auditor and translator

    Both parties

    About 1 week


    Rectifying the nonconforming items pointed out by the FDA

    Both parties

    About 2 weeks