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.
When Apparel Becomes a Medical Device
Lessons from FDA’s Breast Binder Warning Letters In December 2025, the FDA issued warning letters to several companies selling breast binders and chest compression garments online. The agency concluded that marketing claims on company websites, like statements about...
FDA Issues 30 Warning Letters to Telehealth Firms
FDA Issues 30 Warning Letters to Telehealth Firms Over Compounded GLP-1 Marketing Claims On March 3, 2026, the U.S. Food and Drug Administration (FDA) announced that it has issued 30 warning letters to telehealth companies for making false or misleading claims...
FDA Warning Letter Cites Key CGMP and Data Integrity Failures
FDA Warning Letter Highlights Fundamental CGMP and Data Integrity Failures The FDA has issued a Warning Letter to A. Nelson & Co. Ltd. citing significant violations of Current Good Manufacturing Practice (CGMP) requirements under 21 CFR Parts 210 and 211 at a...
Do Not Blame FDA for Lax Oversight of Dietary Supplements
A Regulatory System Designed to Fail The recent recalls involving contaminated moringa leaf powder should alarm every company that manufactures, imports, or sells dietary supplements in the United States. They highlight a reality that consumers rarely understand, and...
FDA Cracks Down on Insightra Medical
Warning Letter Cites a Number of Serious Violations In a scathing warning letter, the FDA has cited Insightra Medical, Inc. for widespread regulatory violations involving its Intra-Aortic Balloon Pump (IABP) Catheter Kit—a device used in critical cardiovascular...
FDA Cracks Down on Illegally Marketed 7-OH Products
Unapproved drugs sold online and in retail locations Yesterday the U.S. Food and Drug Administration (FDA) issued seven warning letters to companies marketing products that contain 7-hydroxymitragynine (7-OH) — a powerful and potentially dangerous opioid-like...
Sterile Drug Manufacturing Violations at Daewoo Pharmaceutical
FDA Cracks Down on Sterile Drug Manufacturing Violations The U.S. Food and Drug Administration (FDA) has issued a warning letter to Daewoo Pharmaceutical Co., Ltd. in Busan, South Korea, citing serious and widespread violations of current Good Manufacturing Practices...
FDA Enforcement
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
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
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...