FDA Drug Factory Inspection


What is the purpose of the FDA drug factory inspection?

The FDA inspection is to ensure that the quality of APIs imported from foreign countries fully meets the requirement of USP. Based on the provisions of the US Government, after the quality inspection for the product sample and the inspection for the relevant facilities of the drug manufacturer, FDA can determine to approve or not approve the drug of a foreign manufacturer to export to the US.

What is the basis of the FDA drug factory inspection?

FDA GMP CFR 210 & CFR 211

What is the frequency of the FDA drug factory inspection?

Usually once every 2 years

Classification of the FDA drug factory inspections?

The FDA drug factory inspections are mainly divided into three classes:

1.  Pre-approval Inspection, i.e., “FDA factory inspection”: inspection for the production of new drugs and generic drugs;

2.  Regular inspection: regular compliance inspection for approved drugs, being biennial inspection in general.

3.  Temporary inspection or supervision based on complaints, recalls or adverse reactions.

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 Drug GMP

2.  Provide the pre-audit service to identify the differences between the enterprise’s current system and the 21CFR PART 111, as well as the regulations for the corresponding types of drugs

3.  On-site accompanying auditor and translator service for the FDA factory inspection

4.  Consultation and response on nonconforming item rectification

5.  Targeted training according to the enterprise’s situation

SUNGO service process



Specific task

Division of work



Establishing and improving the system that meets the 21CFR PART 111

Both parties

4-8 weeks


Identifying the differences between the enterprise’s current system and the 21CFR PART 111 and proposing the rectification suggestions

Both parties

4-8 weeks


Inspecting the rectification of the differences

Both parties

1-2 weeks


Serving as the accompanying auditor and translator

Both parties

About 2 weeks


Rectifying the nonconforming items pointed out by the FDA

Both parties

About 2 weeks