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.