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Compliance Enforcement Actions Manufacturers

Compliance programs typically refer to formalized institutional procedures within corporations and organizations to detect, prevent and respond to indvidual and widespread instances of regulatory violations. ... more +
Compliance programs typically refer to formalized institutional procedures within corporations and organizations to detect, prevent and respond to indvidual and widespread instances of regulatory violations.  In response to many corporate scandals evidencing rampant unethical business practices, many nations, including the United States, began passing strict regulatory frameworks aimed at curbing these abuses. Notable pieces of legislation in this area include the U.S. Foreign Corrupt Practices Act (FCPA), Sarbanes-Oxley (SOX), and the U.K. Bribery Act, to name a few. The foregoing statutes and the severe penalties often associated with them form the basis of many modern institutional compliance programs. less -
Cozen O'Connor

The State AG Report – 07.17.2025

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Here are curated AG and federal regulatory news stories highlighting key areas in which state and federal regulators’ decisions are having an impact across the US: •Democratic AGs Oppose Washing Away Appliance Efficiency...more

Gardner Law

Change Control Pitfalls: Legal & Regulatory Risks in FDA-Regulated Industries

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Obtaining FDA clearance or approval is just the beginning of a company’s regulatory journey. As FDA-regulated products evolve, changes to software, labeling, manufacturing processes, and design are a natural part of the...more

Wiley Rein LLP

Wiley Consumer Protection Download (July 15, 2025)

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FTC Sends Warning Letters Regarding Potential Noncompliance With “Made in USA” Requirements. On July 8, the FTC sent letters to a flagpole retailer, footwear maker, football equipment company, and personal care products...more

Mintz

[Podcast] Health Law Diagnosed – Best Practices for Communicating with the FDA

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In the latest episode of Health Law Diagnosed , Of Counsel Bridgette Keller hosts a discussion of best practices for interacting and communicating with the FDA. Hear from Joanne Hawana and Ben Zegarelli, FDA specialists...more

Skadden, Arps, Slate, Meagher & Flom LLP

OIG Issues Unfavorable Advisory Opinion: Provision of Free Services to Referral Sources Creates Kickback Risk

Key Points - - The Office of Inspector General of the Department of Health and Human Services (OIG) has issued Advisory Opinion No. 25-04 (AO 25-04), its first advisory opinion of the year addressing a proposed arrangement...more

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

Mitchell, Williams, Selig, Gates & Woodyard,...

Energy Efficiency Enforcement: California Energy Commission and Battery Charger Manufacturer Enter into Settlement Agreement and...

The California Energy Commission (“CEC”) and Stanley Black & Decker, Inc. (“Black & Decker”) entered into a May 21st Settlement Agreement and Release (“Agreement”) addressing alleged violations of the California Appliance...more

Gardner Law

Staying Prepared Amid FDA Changes

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Despite recent staffing reductions and leadership transitions at the FDA, pharmaceutical and medical device manufacturers should not interpret these changes as a signal of reduced regulatory enforcement. On the contrary, the...more

Dentons

Ep. 63 – Speaking Fees and Safe Harbors: Lessons from a $202M AKS Settlement

Dentons on

In April, a pharmaceutical manufacturer agreed to pay a $202 million settlement to resolve allegations of Anti-Kickback Statute (AKS) violations. At the heart of the case were speaker programs, where physicians and...more

Arnall Golden Gregory LLP

Surprise, Surprise: FDA Announces Plans to Increase Number of Unannounced Inspections at Foreign Manufacturing Facilities

In their song, “Surprise, Surprise,” the Rolling Stones lamented about being caught off guard by a disappointing relationship. Sixty years later, foreign manufacturers may face the surprise of an unannounced inspection by the...more

Mitchell, Williams, Selig, Gates & Woodyard,...

Hazardous Waste Enforcement: Tennessee Division of Solid Waste Management Proposed Order and Assessment Addressing Ripley...

The Tennessee Division of Solid Waste Management (“TDSWM”) issued a February 7th Proposed Director’s Order and Assessment (“Order”) to SRG Global Coatings, LLC (“SRG”). See Case No. HWM 24-0024. The Order provides that...more

Mitchell, Williams, Selig, Gates & Woodyard,...

OSHA Enforcement: Penalty Assessment Addressing Conyers, Georgia Biolab

The Occupational Safety and Health Administration (“OSHA”) issued a news release stating that it is proposing to impose penalties against Bio-Lab Inc. (“BLI”). The news release states that OSHA determined that the BLI...more

Mitchell, Williams, Selig, Gates & Woodyard,...

Efficiency Standards Enforcement: California Energy Commission and City of Industry Computer Manufacturer Enter into Settlement...

The California Energy Commission (“CEC”) and Sceptre, Inc. (“SI”) entered into an March 24th Settlement Agreement and Release (“Settlement”) addressing alleged violations of Appliance Efficiency Regulations at California Code...more

Mitchell, Williams, Selig, Gates & Woodyard,...

Hazardous Waste Enforcement: Alabama Department of Environmental Management and Huntsville Circuit Board Manufacturing Facility...

The Alabama Department of Environmental Management (“ADEM”) and Sanmina Corporation (“SC”) entered into a Consent Order (“CO”) addressing alleged violations of the Alabama Hazardous Waste Regulations. See Consent Order No....more

Mitchell, Williams, Selig, Gates & Woodyard,...

Hazardous Waste Enforcement: Alabama Department of Environmental Management and Marshall County Specialty Tank Manufacturer Enter...

The Alabama Department of Environmental Management (“ADEM”) and Pinnacle Manufacturing, LLC (“Pinnacle”) entered into a March 5th Consent Order (“CO”) addressing alleged violations of the Alabama Hazardous Waste regulations....more

IR Global

From Disaster to Reform: The Ongoing Legal Legacy of Grenfell Tower

IR Global on

In the wake of the Grenfell Tower tragedy in 2017, which claimed 72 lives, the UK government has undertaken significant measures to address the systemic failures that contributed to the disaster. This year, several key...more

IR Global

Major Updates to Colorado Liquor Laws

IR Global on

As of January 1, 2025, the Colorado Department of Revenue’s Liquor and Tobacco Enforcement Division implemented new liquor rules to enforce SB24-231, which became law in 2024. The new law vastly modified the alcohol industry...more

Morrison & Foerster LLP

What to Expect from CPSC in 2025

At the end of last year, the Consumer Product Safety Commission (CPSC) approved an Operating Plan for Fiscal Year 2025, which includes CPSC’s strategic priorities and resource allocations for the coming year. Stated...more

McGlinchey Stafford

Manufacturer’s EPA Compliance Audits: Regulatory Expectations Under Trump 2.0

McGlinchey Stafford on

The regulatory landscape likely to characterize President Donald Trump’s second term will create important implications for conducting U.S. Environmental Protection Agency (EPA) compliance audits within the manufacturing...more

Pillsbury - PFAS Observer

New York and California’s Restrictions on PFAS in Apparel Takes Effect

New York and California have recently imposed sweeping prohibitions on the sale of apparel containing per- and polyfluoroalkyl substances (PFAS). These prohibitions have a broad scope and are effective and enforceable as of...more

Morrison & Foerster LLP

FDA Issues Action Levels for Lead in Baby Food

On January 6, 2024, the U.S. Food and Drug Administration (FDA) issued its final guidance establishing action levels for lead in processed food intended for babies and young children. This is the first FDA guidance directly...more

Robinson+Cole Manufacturing Law Blog

Recent Federal Strike Force Prosecutions Serve as Warning to U.S. Manufacturers and Other Exporters

The recent enforcement activities of the newest federal strike force serve as a warning to U.S. manufacturers and other businesses involved in the export of products that the government is doubling down on prosecuting trade...more

Barnea Jaffa Lande & Co.

Israel: Increased Enforcement of Packaging Law

Recently there has been a significant increase in administrative enforcement proceedings, warning letters and motions to certify class actions in relation to the Processing of Packaging Law. The law, enacted back in 2011,...more

Womble Bond Dickinson

Federal Trade Commission Strikes Against “Crafted in America” Language

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As previously reported by Home Textiles Today, the Federal Trade Commission (FTC) has announced a “record civil penalty” of $3.175 million against a retailer who failed to tell the truth about whether the products it sells...more

Gardner Law

FDA Issues Numerous Warning Letters

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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

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