The Different Types of FDA Inspections: What You Need to Know

For those manufacturing drugs, medical devices, or anything else regulated by the United States Food and Drug Administration (FDA), an inspection conducted by the FDA is expected. Inspections are to verify that the manufacturers are compliant with any and all regulations. 

Any facility or manufacturer in the United States is under FDA jurisdiction and will have to undergo some, if not all, of the below inspections. Also, if a foreign manufacturer is planning on selling their product in the United States, they are required to receive FDA approval and to pass the necessary inspections. To be prepared, it is good to know the four main types of FDA inspections.

Pre-Approval Inspections

This inspection is for new products that have been submitted to the FDA for initial approval. After receiving the application, the inspection is conducted to verify the validity of the information presented in the application. 

The inspectors also will confirm the capability of the facility in question to manufacture the drug or device. After this inspection, the inspectors that conducted it will recommend for or against approval by the FDA.

Routine Inspections

For class II and class II device manufacturers, routine inspections are required by law every two years. This inspection is conducted following a method called the Quality System Inspection Technique (QSIT). 

QSIT breaks down the processing system into four subsystems and inspectors will use this method to either investigate one or all four subsystems depending on risk-level and if it is the initial or subsequent routine inspection. 

Compliance Follow-Up Inspections

Follow-up inspections are in response to a previous inspection and are to review the requested actions taken by the manufacturer. If an inspection led to a Warning Letter or a completed 483 Form, it will be necessary to follow-up with the manufacturer. 

The 483 Form is to document concerns found during an inspection and communicate these to the manufacturer. The follow-up inspection will verify compliance or give support for further regulatory action in the case that recommendations were not followed. 

For Cause Inspections

If there has been a specific problem about a drug or device that was reported to the FDA, this will trigger a “for cause” inspection. The report of the problem could come directly from the manufacturer, in the form of a recall, or be in the form of a complaint by a user of the drug/device. 

These inspections are usually focused on the specific problem reported, but findings could lead to a wider inspection into seemingly unrelated parts of the operation. 

CfPIE: Your Answer to Preparing for FDA Inspections

Are you looking to learn more about the FDA inspection process? All FDA-related industry professionals will benefit from understanding and being prepared for FDA inspections. 

Pre-approval and routine inspections are announced five days prior but follow-up and “for cause” inspections are unannounced. Our course, “What Regulators Expect and How to Prepare,” will provide you with the information and tools they require to prepare for and manage an FDA inspection.

Have questions? Get in touch with a member of the CfPIE team by calling 1-610-648-7550 or emailing info@cfpie.com.