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Understanding the 4 Types of FDA Inspections

Understanding the 4 Types of FDA Inspections is a MED DEVICE ONLINE Guest Expert Series by Halloran.

If you are a manufacturer or a processor of FDA-regulated products, sooner or later, you can expect a visit from FDA. The purpose of this visit is to verify compliance with all relevant regulations — most commonly referred to as an FDA inspection. But not all inspections are created equal.

FDA performs four different types of inspections at many different types of facilities, and your company’s response should be tailored to the specific type of event. Facilities that fall under FDA’s watchful eye include:

FDA’s inspection authority also extends to foreign manufacturing and processing sites for FDA-regulated products sold in the United States. Fall within these bounds, and you can anticipate an FDA inspection at your facility. For the scope of this article, though, we will focus specifically on the inspection of medical device manufacturers.

The four different types of FDA inspections are pre-approval inspection, routine inspection, compliance follow-up inspection, and “for cause” inspection.  Each is intended to help protect the public from unsafe products, but the focus and expectations of each type of inspection are different.

Pre-Approval Inspections are conducted after a company submits an application to FDA to market a new product. These inspections focus on verifying data included in the application, and confirming that the facility is capable of manufacturing said product. The outcome of a pre-approval inspection is that inspectors will recommend for or against FDA approval.

Routine Inspections are mandated by law every 2 years for class II and class III device manufacturers.  They follow a prescribed method known as Quality System Inspection Technique (QSIT), which will be discussed later in the article. If a serious public health risk is identified during a routine inspection, the inspection type may then switch to a “for cause” inspection.


Read the rest of the article here, at Med Device Online.