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