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Gardner Law

What to Do When FDA Detains Your Shipment

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When products in your shipment violate—or appear to violate—FDA laws and regulations, the FDA may detain your product and issue a Notice of FDA Action with the designation of “Detained.” This notice is considered the Notice...more

Stinson LLP

Check Your LED Lighting Supplies and Construction Materials or It Could Cost You

Stinson LLP on

Recently the Federal Trade Commission entered into a settlement under which Patriot LED must pay civil damages of nearly $158,000, plus a penalty of $2.96 million, for its alleged false marketing of lighting products as...more

Hogan Lovells

FDA Issues First Warning Letter for Foreign Supplier Verification Program Violations under FSMA

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The U.S. Food and Drug Administration (FDA) recently issued the first Warning Letter addressing violations of the Foreign Supplier Verification Program (FSVP) rule, one of the seven major FDA Food Safety Modernization Act...more

Hogan Lovells

Medical Device Contractor Settles FCA Allegations Based on TAA Violations

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On Thursday, August 8, 2019, the Department of Justice (“DoJ”) announced that Danish medical device company Ambu, Inc. (“Ambu”) will pay $3.3 million to settle False Claims Act (“FCA”) allegations that it violated the Trade...more

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