News & Analysis as of

Inspections

For the Benefit of Mr. Kite – Fiction in the World of Quality Assurance

by Thomas Fox on

The basics were laid out by Peter Wells and Emiko Terazono in a Financial Times (FT) article entitled “Kobe Steel scandal hits Boeing, Toyota and Nissan”. The Japanese company admitted it had falsified “inspection data on an...more

“Challenges Remain” for FDA’s Inspections of Food Facilities, According to Inspector General Report

by Kelley Drye & Warren LLP on

While FDA is on track to meet the initial inspection timeframes specified under the Food Safety Modernization Act (FSMA), questions remain about the effectiveness of those inspections and the capacity for FDA to meet future...more

A Client's Guide to FDA Inspections

A Food and Drug Administration (FDA) inspector has just knocked on your door and announced that he or she will now inspect your facility. What happens before, during and after this inspection, and what should your firm do to...more

FDA Implements a New “Concept of Operations” for Drug Inspections

The Food and Drug Administration (FDA) has announced implementation of a new “concept of operations” that seeks to improve FDA’s oversight over pharmaceutical manufacturers. The concept of operations complements FDA’s program...more

Identifying and Addressing Environmental Issues in Petroleum Marketing Agreements (“Presentation”)

The Arkansas Oil Marketers Association Environmental Workshop was held on August 30th in Little Rock. I undertook a presentation titled: Identifying and Addressing Environmental Issues in Petroleum Marketing...more

The Importance of Documenting Flood Damage

by Jackson Walker on

As the effects of Hurricane Harvey begin to dissipate, a number of you have asked another important, practical question: Can I and should I start making temporary repairs and/or removing damaged items from my home?...more

FDA, EU Regulators Agree to Share Unredacted Inspection Reports and Other Confidential Information

by Hogan Lovells on

The U.S. Food and Drug Administration (FDA), the European Medicines Agency (EMA), and the European Commission – DG Sante (DG Sante), signed a new confidentiality commitment which expands the scope of the current...more

OSHA To Hold Second Public Meeting To Discuss Voluntary Protection Programs

by Cozen O'Connor on

As generally expected under a Republican administration, OSHA appears more focused on compliance and a collaborative working relationship with businesses. As part of this strategy, OSHA recently announced it will hold its...more

Increase in Chemical Security Vulnerability Assessments Likely Under New DHS Standards

by Williams Mullen on

The Department of Homeland Security (DHS) Chemical Facility Anti-Terrorism Standards (CFATS) program identifies and regulates high-risk chemical facilities to ensure that security measures are in place to reduce the risk of...more

Foreign device manufacturers should anticipate greater chance of FDA inspection under new FDA leadership

by Hogan Lovells on

Under the Trump administration, foreign device manufacturers may see new compliance pressures and increased inspections by the FDA. In this video, Michael Heyl discusses this growing trend and shares insights on how foreign...more

New NYC Law Obliges Mobile Food Vendors To Display Sanitary Inspection Grades

by Cole Schotz on

On May 30, 2017, Mayor de Blasio signed into law Int. No. 1456, requiring mobile food vendors (food trucks, hotdog carts, etc.) to display letter grades received after sanitary inspections akin to those displayed in windows...more

Developer bonds and defect inspection regime postponed again

by Dentons on

The NSW Government has again postponed the commencement of the new developer bond and defect inspection regime under Part 11 of the Strata Schemes Management Act 2015 (Act). The regime was proclaimed to commence on 1 July...more

What to do when the government comes calling: A checklist for handling facility inspections

by Thompson Coburn LLP on

It’s a sunny Friday afternoon and you’re at your desk looking forward to your weekend plans when you get a call from security: Government inspectors are at the front gate and want to perform an inspection of the facility —...more

OSHA Provides Enforcement Guidance on Workplace Violence Response

When does an incidence of workplace violence rise to the level of a federal case? The Occupational Safety and Health Administration (OSHA) has updated its guidance on just that issue. The OSH Act’s General Duty Clause...more

OSHA Rescinds Union Walk Around Letter

by Jackson Lewis P.C. on

In February 2013, OSHA issued an interpretation letter in response to a request from the United Steel, Paper and Forestry, Rubber, Manufacturing, Energy, Allied Industrial and Service Workers International Union, which...more

Are You Exempt? FDA Announces Waivers for Certain Businesses Subject to the Sanitary Transportation Rule

by Dickinson Wright on

The FDA Food Safety Modernization Act (FSMA) rule on Sanitary Transportation of Human and Animal Food is now final and on April 5, 2017, the FDA published three waivers for certain qualifying businesses. The Sanitary...more

EU-U.S. Agreement for Mutual Recognition of GMP Inspections Entered Into Force

by Jones Day on

On March 4, 2017, the "Decision No 1/2017 of March 1, 2017, of the Joint Committee established under Article 14 of the Agreement on Mutual Recognition between the European Community and the United States of America, amending...more

Avoiding An ICE Raid

by Fisher Phillips on

It has been fewer than 100 days since Donald J. Trump became the 45th President of the United States of America. In this short time, there has been a flurry of immigration-related activity, which has caused the national...more

Environmental Notes - April 2017

by Williams Mullen on

Most industrial facilities will, at some point, be inspected by an environmental regulatory agency. Generally, regulatory agencies have authority to enter public or private property that is governed by an environmental...more

Successfully Managing Environmental Regulatory Inspections

by Williams Mullen on

Most industrial facilities will, at some point, be inspected by an environmental regulatory agency. Generally, regulatory agencies have authority to enter public or private property that is governed by an environmental...more

Motor Carriers Be Aware: The CVSA’s 30th Annual International Roadcheck is Coming to a Highway Near You on June 6-8, 2017

by Benesch on

The Commercial Vehicle Safety Alliance (“CVSA”) has announced that its 30th annual International Roadcheck will occur June 6-8, 2017. This year’s Roadcheck will place a particular emphasis on cargo securement safety....more

Massachusetts Supreme Judicial Court Clarifies the Requirements for Shareholder Inspection Demands

by Goodwin on

In Chitwood v. Vertex Pharm. Inc., SJC-12101 (March 20, 2017), the Massachusetts Supreme Judicial Court (SJC) provided important guidance on the scope of the Massachusetts shareholder inspection statute, Mass. G.L. 156D §...more

State Water Board Releases Draft Emergency Regulation Setting Fees For SGMA Intervention

by Best Best & Krieger LLP on

In a new regulatory step under the Sustainable Groundwater Management Act, the State Water Resources Control Board released a draft emergency regulation that sets fees for state intervention activities. Comments are due by...more

U.S. FDA and EU Regulators Announce Enhanced Mutual Recognition for Pharmaceutical Manufacturing Inspections; Allows FDA to...

by Hogan Lovells on

In an effort to avoid the duplication of drug inspections, lower inspection costs, and enable regulators to devote more resources to other parts of the world where there may be greater risk, the U.S. Food and Drug...more

US SEC Publishes Risk Alert on Top Five Investment Adviser Compliance Issues Found During Inspections

by Dechert LLP on

The Office of Compliance Inspections and Examinations (OCIE) of the U.S. Securities and Exchange Commission (SEC) issued a National Exam Program Risk Alert on February 7, 2017 (Risk Alert), highlighting the “five compliance...more

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