FDA Cosmetics Factory Inspection
What is the basis of the FDA cosmetics factory inspection?
CGMP
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
Process |
Specific task |
Division of work |
Cycle |
1 |
Establishing and improving the system meeting the Cosmetic GMP |
Both parties |
2-4 weeks |
2 |
Identifying the differences between the enterprise’s current system and the Cosmetic GMP and proposing the rectification suggestions |
Both parties |
1-2 weeks |
3 |
Inspecting the rectification of the differences |
Both parties |
1-2 weeks |
4 |
Serving as the accompanying auditor and translator |
Both parties |
About 1 week |
5 |
Rectifying the nonconforming items pointed out by the FDA |
Both parties |
About 2 weeks |