FDA Enforcement

FDA Enforcement

The Food and Drug Administration is responsible for enforcing the federal Food, Drug and Cosmetic Act. It enforces that law and related regulations to ensure compliance by every entity involved with a regulated product.

This includes regulation of processes involved in:

• Design
• Production of components and finished products
• Packaging, and
• Post-production processes like sterilization, labeling and distribution, and post-market surveillance; until the end of the effective life cycle of that product.

FDA Enforcement Tools

The FDA uses several regulatory tools to maintain cognizance over the safety and efficacy of regulated products.

One of the agency’s primary enforcement tools is on-site inspections performed by FDA inspectors, which can result in “483” noncompliance findings that often lead to warning letters and other enforcement actions.

Other tools include enforcing requirements for the market approval of products, documentation of manufacturer and supplier regulated processes, and reporting of product issues, among others. It also utilizes several methods to notify the public of product issues and health threats they may present.

The FDA communicates to manufacturers and other responsible parties to issue warnings, invoke punishments, and require enforcement actions like product recalls and corrections. And although the agency shares that information on its website it can be difficult and time-consuming to find the specific, most recent information.

Medical Devices and Pharma presents the various types of FDA information in a format and structure that makes it more accessible to consumers and industry.

Read more about FDA enforcement.