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 |
