What are the 4 types of FDA inspections?

Types Of FDA Inspections

If the organization is manufacturing drugs or drug devices or it is the processor of the USFDA product, then the organization is bind to go through FDA inspection.

There are 4 types of FDA inspection in pharmaceuticals. Each inspection type is intended to help protect the public from unsafe products, but their focuses and expectations are different.

FDA inspections are conducted to verify the compliance of regulations recommended by the regulatory agency.

A company’s response to an FDA inspection should be tailored to the specific type of event. USFDA conducts four types of FDA inspections at many different types of facilities.

What does FDA Inspect?

FDA inspect the different types of facilities as follows:

  1. Vaccine and Drug Manufacturer
  2. Device Manufacturer
  3. Laboratories for animal studies
  4. Animal feed processors
  5. Food processing facilities
  6. Blood banks
  7. Facilities that conduct people’s studies.
  8. Dairy farms
  9. Suitable compounding pharmacies for FDA inspection
  10. Testing laboratories

Types of FDA inspections in Pharmaceutical

The USFDA conducts four types of FDA inspections:

  1. Pre-approval inspection
  2. Routine Inspection
  3. Compliance Inspection
  4. “For Cause” Inspection

1. Pre-approval Inspection

If you want to market the product in the US, pre-approval of the product is a must. Once the organization submits the application to the FDA, then FDA is ready to conduct the inspection. It is a pre-approval inspection of the FDA. This FDA inspection basically conducts to know the facility and capability of the manufacturing site of the drug product that market to the US.

The outcome of the FDA inspection depends on how the manufacturing site is ready and follows compliance for the product. Either the facility is working according to the FDA inspection checklist. On the basis of that, it can be a recommendation for the manufacturing of drug products or a recommendation for better performance.

Also Read:

Difference between Form 482 483 and 484

Reasons for warning letter to employee

2. Routine Inspection

In early days the routine inspection is conducted after every 2 years. But nowadays inspection can be happened at any time.

In routine inspection FDA inspector visit the site and inspect the manufacturing facility and the compliance. If in routine inspection, any serious violation is observed with respect to patient’s safety or health safety, the inspector may issue observation on “FORM 483”.

FDA Auditors may come with FDA audit checklist to inspect the facility and if found non-compliance FDA may issue the “FDA 483 letter” or “FDA warning letter” for a serious violation to the manufacturing site.

In order to inspect quality systems, they utilize a technique known as Quality System Inspection Technique (QSIT).

There are two levels of routine QSIT inspection:

Level 2 Baseline QSIT Inspection:

Baseline QSIT inspections are conducted every six years when a company does not have a Level 2 inspection before. The inspection is intended to provide an overall evaluation of the quality system.

Level 1 Abbreviated QSIT Inspection:

Generally, Level 1 Abbreviated QSIT inspections are performed after the firm has gone through a Level 2 inspection, and it has been determined that the quality system is compliant.

The CAPA subsystem always appears in a Level 1 inspection, and one other major subsystem will appear at each subsequent Level 1 inspection.

3. Follow-up Inspection

Inspections that track the actions taken by firms and manufacturers in response to earlier inspections that resulted in significant observations or a Warning Letter are considered Compliance Follow-Up Inspections.

Normally, a compliance follow-up entails verifying whether previous violations were adequately corrected, documenting ongoing violations, or supporting future compliance control actions.

4. “For Cause” Inspection

During a “For Cause” Inspection, FDA examines a specific problem that has been reported to them, either by the manufacturer, consumers or employees. In an on-demand inspection, the firm is asked to turn over documents, but other non-critical elements of its operations can be examined as well.

Inspections such as these are usually requested by CDRHs, ORAs, or regional directives. These inspections tend to be much more in-depth than routine ones, and may not follow an FDA QSIT (Quality System Inspection Technique) approach.

I hope you understand the types of FDA inspections and what FDA can inspect.


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