FDA Food Factory Inspection
What is the basis of the FDA food factory inspection?
21CFR PART 111 and regulations for the corresponding types of food
What is the frequency of the FDA food factory inspection?
The US Food and Drug Administration (FDA) conducts random checks on the registered food enterprises every year to confirm whether the registered enterprises comply with the FDA regulations.
What is the FDA factory inspection notification form?
The FDA generally notifies the enterprises and US agents by emails.
Will the FDA give the factory inspection notification in advance?
Under normal circumstances, the audit notification will be sent 1-2 months in advance. However, it is also possible that the FDA officials notify the enterprise after arriving at the factory.
What to do after receiving the FDA factory inspection email?
As a global technical service provider that is professional in the field of medical device regulations, SUNGO can provide the following services:
1. Assist the enterprise to establish a quality management system that meets the requirements of the Food GMP
2. Identify the gap between the existing QMS and regulatory requirements
3. Review the document record and check the GMP of the whole production process and the GMP of the equipment and facilities maintenance based on the FDA review requirements; the counselor and the relevant personnel of the enterprise correct the document system jointly;
4. Identify and correct the defects of workshops and warehouses;
5. Provide the audit skill training for relevant personnel of the enterprise;
6. Our auditor will conduct a simulated audit on the effectiveness of the system before the FDA audit;
7. Accompany the FDA factory inspection and serve as a translator;
8. Assist the enterprise to correct the nonconforming items.
SUNGO service process
Division of work
Establishing and improving the system that meets the requirements of the Food GMP
Identifying the differences between the enterprise’s current system and the Food GMP and proposing the rectification suggestions
Inspecting the rectification of the differences
Serving as the accompanying auditor and translator
About 1 week
Rectifying the nonconforming items pointed out by the FDA
About 2 weeks