Types of FDA inspections
The FDA conducts several types of inspections to help provide access to needed medical products and to protect consumers and patients from unsafe products:
- Surveillance inspections are conducted to monitor the manufacturing process and the quality of FDA regulated products on the market. The agency uses the inspection to evaluate whether a manufacturer is complying with quality manufacturing practices.
- For-cause inspections are triggered when the agency has reason to believe that a facility has quality problems, to follow up on complaints or to evaluate corrections that have been made to address previous violations.
- Application-based inspections are conducted for about 20% of the application reviews conducted by the agency. These inspections are part of the application review process to market a new drug, device or biologic to determine whether the new product is manufactured in compliance with FDA regulations and to ensure the facility is capable of manufacturing the product consistently and that submitted data are accurate and complete. Additionally, the agency conducts inspections of tobacco facilities as part of the premarket review of tobacco applications.
- The agency also conducts inspections to verify the reliability, integrity and compliance of clinical and non-clinical research being reviewed in support of pending applications.
Inspections can be a comprehensive review of the entirety of operations at a facility or can be directed, sometimes referred to as a limited inspection, at a particular issue or issues, such as to ensure compliance with recall actions or to follow up on a corrective action in the facility.
Risk-based approach to inspections
The FDA uses a risk-based evaluation to select foreign and domestic medical product manufacturing facilities for inspection The agency prioritizes medical product surveillance inspections deemed high-risk based on a variety of specific criteria, such as:
- facility type, such as manufacturer, control laboratory, etc.
- the facility’s compliance history, including whether it has been inspected in the last four years
- hazard signals, including the record of signals, history and nature of product recalls linked to the facility, etc.
- inherent risks of the product manufactured at a facility, such as dosage form, route of administration, products intended to be sterile, concentration of active pharmaceutical ingredient in dosage form, emergency use, etc.
- whether the facility has been inspected by a foreign regulatory partner
For example, a sterile drug manufacturing site that has not been previously inspected and is making narrow therapeutic index drugs would likely be deemed a higher risk than a site that had a well-known inspectional and compliance history that is making over-the-counter solid oral dosage form drugs.
For bioresearch monitoring (clinical and non-clinical research) inspections, the agency considers several risk-based factors, including:
- compliance history
- complaints associated with the site
- number of applications the site is associated with
- enrollment numbers
- number of protocol exceptions/deviations
- data anomalies
Human and animal food inspections are driven by the Food Safety Modernization Act inspection frequency mandate that requires domestic high-risk facilities to be inspected every three years and non-high-risk facilities are inspected every five years.