Food and Drug Administration (FDA) – Quality Audits and Inspections
20 Sep 2024
FDA ensures that the medical products placed inside the U.S. market comply with its strict standards for quality, safety, and effectiveness. The agency uses risk-based methods to select foreign and domestic facilities for inspection.
FDA Inspections
An inspection is a detailed, official onsite examination of a facility to check its compliance with federal laws. While inspections are crucial for FDA oversight, they provide only a glimpse of activities occurring in the facility being inspected. Therefore, these inspections are just one part of the FDA’s comprehensive approach to ensuring the safety and quality of regulated products.
The products made outside the U.S. must meet the same standards as those made inside the U.S. The FDA closely monitors the global supply chain to ensure Americans can trust the safety and quality of their products, regardless of where they are manufactured.
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What Does the FDA Inspect?
The FDA inspects manufacturers of FDA-regulated products to ensure they follow the relevant regulations, including:
- Vaccine and drug manufacturers
- Blood banks
- Food processing facilities
- Dairy and produce farms
- Animal feed processors
- Outsourcing facilities and compounding pharmacies
- Tobacco manufacturers
The FDA also inspects:
- Facilities conducting clinical trials
- Laboratories conducting animal or microorganism studies for FDA approval of medical products
- Foreign manufacturing and processing sites for FDA-regulated products sold in the U.S.
- Imported regulated products at the border
Types of FDA Inspections
The FDA performs various types of inspections to ensure safe access to essential medical products and protect consumers and patients from unsafe items. Important types of FDA inspections include:
- Surveillance Inspections:
Surveillance inspections are carried out to monitor the manufacturing process and the quality of FDA-regulated products on the market. These inspections help the agency assess whether manufacturers are following good manufacturing practices.
- For-cause Inspections:
For-cause inspections occur when the FDA suspects quality issues at a facility, needs to follow up on complaints, or assess corrections made to address past violations.
- Application-based Inspections:
Application-based inspections are conducted as part of approximately 20% of the FDA’s application reviews. These inspections are integral to the process of reviewing new drugs, devices, or biologics for market approval. They ensure the product is manufactured in compliance with FDA regulations, confirm the facility’s capability for consistent production, and verify the accuracy and completeness of submitted data. The FDA inspects tobacco facilities as part of the pre-market review process for tobacco applications. The FDA also conducts inspections to ensure the reliability, integrity, and compliance of both clinical and non-clinical research that supports pending applications.
Inspections can also be thorough reviews covering all operations at a facility. They can also be targeted in their scope (also known as limited inspections). These inspections mostly focus on specific issues as ensuring compliance with recalls or following up on corrective actions.
Classifications of Inspection
Current Good Manufacturing Practice (CGMP) requirements produced high quality and safe drugs. FDA inspections are conducted to assess whether drug manufacturers are compliant with CGMPs.
After an inspection, the agency assesses the findings to determine if the facility complies with laws and regulations, and then classifies the inspection:
- No Action Indicated (NAI) which means no concerning conditions or practices were identified during the inspection.
- Voluntary Action Indicated (VAI) which means objectionable conditions or practices were found, but the agency is not currently planning to take or recommend any administrative or regulatory action.
- Official Action Indicated (OAI) which means regulatory and/or administrative actions are recommended.
The agency decides the final inspection classification based on information gathered during the inspection and from the facility’s responses afterward. When FDA investigators found issues during an inspection, they use Form FDA 483 (i.e. document than notify the company’s management of objectionable conditions) to document their observation related to CGMP compliance. The agency keeps an inspection data dashboard on FDA.gov, updated weekly, which includes final inspection classifications. Once an inspection is classified and closed, it is added to this database. However, not all inspections are recorded in the database, such as inspections conducted by states, pre-approval inspections, mammography facility inspections, inspections pending final enforcement action, and inspections of nonclinical labs.
FDA’s Risk-Based Approach to Inspections
The FDA uses a risk-based approach to choose which foreign and domestic medical product manufacturing facilities to inspect. The agency gives priority to surveillance inspections for high-risk medical products, based on specific criteria including:
- Facility type (e.g., manufacturer, control laboratory, etc.);
- Compliance history, including recent inspections within the last four years;
- Hazard signals, such as product recall records and history;
- Inherent risks of the products made (e.g., dosage form, sterility, concentration of active ingredients etc.);
- Previous inspections by foreign regulatory partners.
For instance, a sterile drug manufacturing facility that hasn’t been inspected before and produces narrow therapeutic index drugs would be considered higher risk compared to a facility with a well-established inspectional and compliance history that makes over-the-counter solid oral dosage form drugs.
For bioresearch monitoring inspections (both clinical and non-clinical research), the agency considers several risk-based factors, including:
- Compliance history
- Complaints linked to the site
- Number of associated applications
- Enrollment numbers
- Protocol exceptions/deviations
- Data anomalies
In short, there are several areas that must be checked by the manufacturing facility preparing for an FDA inspection.
Are you ready for your next FDA inspection?
FDA ensures that all the medical devices and drug manufactures fulfill its regulatory requirements. For this purpose, it conducts regular audits and on-site inspections of these facilities. If manufacturers cannot comply with FDA’s requirements, they face severe repercussions. Our regulatory experts will ensure that you are prepared for upcoming FDA inspection. If you want to succeed in your next FDA inspection, book a consultation session today.
