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Manufacturers › Noncompliance › Enforcement Actions

Gardner Law

FDA Issues Numerous Warning Letters

Gardner Law on

The U.S. Food and Drug Administration (FDA) uses warning letters to notify manufacturers that they have violated the FDA’s regulations or federal law. Manufacturers that receive warning letters must respond promptly, and they...more

Mintz - Health Care Viewpoints

Hefty Fine is a Reminder of FCC’s Purview Over Certain Personal Hygiene and Wellness Devices

Mintz - Health Care Viewpoints on

Do you manufacture, import, or market personal hygiene and wellness devices sold in drugstores? If so, you may be focused on U.S. Food and Drug Administration (FDA) compliance, but may not have considered the requirements of...more

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