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Enforcement Actions Risk Management Manufacturers

Cozen O'Connor

OSHA Renews Focus On Amputations In Manufacturing

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OSHA recently renewed its national emphasis program focused on preventing amputations in manufacturing, effective June 27. The national emphasis program will remain in place for five years, and programmed inspections may...more

Conn Maciel Carey LLP

Don’t Get Caught Off Guard: OSHA Renews Its Machine Safety (Amputations) National Emphasis Program

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OSHA announced that it is renewing its National Emphasis Program (NEP) to Address Amputations in Manufacturing. The renewed NEP will replace the previous version which expired on June 27 and will remain in place for five...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

Littler

OSHA Renews its National Emphasis Program on Amputations in the Manufacturing Industry

Littler on

The U.S. Department of Labor’s Occupational Safety and Health Administration renewed its National Emphasis Program on Amputations in Manufacturing Industries (NEP) on June 27, 2025, superseding the prior version. This new NEP...more

McGuireWoods LLP

Retailers at Risk: FDA Issues Advisory on Recreational Nitrous Oxide Products

McGuireWoods LLP on

On June 4, 2025, the U.S. Food and Drug Administration issued a public advisory urging consumers not to inhale nitrous oxide (N2O) from commercial dispensers, including canisters, tanks and portable chargers. The advisory...more

Foley & Lardner LLP

Customs Fraud Makes the Big Leagues: DOJ’s New White-Collar Priorities Confirm Heightened Risk

Foley & Lardner LLP on

Last month, the Department of Justice put trade, customs, and tariff fraud squarely in the spotlight. This isn’t just another line item on the compliance checklist, it’s a loud-and-clear signal that import-related enforcement...more

Perkins Coie

Psychoactive Kratom Draws Continued Scrutiny and Legal Action

Perkins Coie on

In recent years, plaintiffs have increasingly set their sights on kratom, a controversial botanical supplement, as a target for litigation. With at least 15 putative class-action cases filed in the past year alone, this...more

Gardner Law

Staying Prepared Amid FDA Changes

Gardner Law on

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

Akin Gump Strauss Hauer & Feld LLP

EPA Speaks on PFAS: What Manufacturers Need to Know

After addressing a number of other programs over the first 100 days of the new administration, on April 28, 2025, the Environmental Protection Agency (EPA) finally addressed PFAS. Administrator Lee Zeldin outlined a number of...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

Bergeson & Campbell, P.C.

Chemical Product Law and Supply Chain Stewardship: A Guide to New TSCA — A Conversation with Richard E. Engler, Ph.D. and Kelly N....

This week, I discuss with my colleagues, Dr. Richard E. Engler, Director of Chemistry for B&C and The Acta Group (Acta®), our consulting affiliate, and Kelly N. Garson, Senior Associate for B&C and Acta, our recently released...more

Hogan Lovells

Prescription Medical Device Manufacturers, Distributors, and the NABP: The Role in State Licensing

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The National Association of Boards of Pharmacy (NABP) plays an important role in the state licensing of prescription medical device manufacturers and distributors. Although the NABP does not directly regulate the...more

American Conference Institute (ACI)

[Event] 15th Forum on Global Encryption, AI, Cloud & Cyber Export Controls - March 26th - 27th, San Francisco, CA

As global trade policy evolves faster than ever, now is the time to connect with your peers, discover new strategies, and most importantly, hear from the regulatory agencies on the front lines of policy change. ACI’s 15th...more

Williams Mullen

Refrigeration Systems Targeted: Risk Management Plans and Release Reporting

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Companies operating ammonia refrigeration systems are easy targets for EPA under a number of environmental programs. Recent history suggests release reporting under Section 112(r) of the Clean Air Act (CAA) and under the...more

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