Enforcement

Consumer-oriented medical device and pharmaceutical information

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.

Device Warning Letters

Pharma Warning Letters

FDA Enforcement

Apr 18, 2024 | FDA Enforcement, US-FDA

The Food and Drug Administration (FDA) in the United States employs various enforcement mechanisms to ensure compliance with regulatory requirements and to protect public health. These mechanisms are essential for maintaining the safety, efficacy, and quality of food,...

FDA Warning Letter to Olympus Medical Systems

Mar 19, 2023 | FDA Enforcement, FDA Warning letters, Med-Devices, US-FDA

Letter addresses several violations of FDA&C Act On March 15, 2023, the Food and Drug Administration (FDA) issued a Warning Letter to Olympus Medical Systems Corp. The letter addressed several violations of the Federal Food, Drug, and Cosmetic Act (FD&C Act)...

FDA Warning Letter to Jackson Clinic

Mar 12, 2023 | Consumer Information, FDA Enforcement, FDA Warning letters, Industry News, Pharmaceuticals, US-FDA

Warning Letter Sites Violations of Law In early February of this year, the U.S. Food and Drug Administration (FDA) issued a Warning Letter to Jackson Health & Wellness Clinic. The business was cited for several violations related to its marketing and...

FDA Posts Warning Letter to MicroVention Costa Rica

Mar 1, 2023 | Alerts, FDA Enforcement, FDA Warning letters, Industry News, Med-Devices, US-FDA

Identifies several violations of the FD&C Act and QSR On February 7, FDA issued a warning letter it had sent to MicroVention Costa Rica SRL on September 30, 2022. The company is a subsidiary of MicroVention Inc., a medical device company based in Tustin,...

FDA Information – Conveniently Organized and Accessible

Dec 31, 2022 | Consumer Information, FDA Enforcement, FDA Public Information, Industry News, Med-Devices, Pharmaceuticals, Product-Innovation, Reg_Information, US-FDA

Quickly find the FDA information you need Conveniently organized FDA information. The U.S. Food and Drug Administration (FDA) provides a wealth of information for consumers and industry stakeholders. The problem is, it can be difficult to navigate to the information...

Safety Alerts