News & Analysis as of

Inspections Audits

Marshall Dennehey

A Hospital’s Metadata is Subject to Inspection in New Jersey Medical Malpractice Matters

Marshall Dennehey on

Key Points: New Jersey’s Appellate Division held that an inspection of a hospital’s electronic medical records, including its metadata, is discoverable despite the risks and burdens of producing such information for review....more

WilmerHale

Recent PCAOB Developments for Audit Committee and Companies

WilmerHale on

The Public Company Accounting Oversight Board (PCAOB) has had one of its busiest years in recent memory, including with respect to standard setting, inspections and enforcement. Below is a summary of notable developments that...more

Ankura

Common PCAOB Inspection Findings and Actions Firms Can Take to Improve Audit Quality and Reduce the Risk of Regulatory Enforcement...

Ankura on

In July 2023, the PCAOB published the spotlight, “Staff Update and Preview of 2022 Inspection Observations.” The article summarized the PCAOB's common findings from its 2022 inspection season. Many of the findings observed in...more

Davies Ward Phillips & Vineberg LLP

Court of Québec Orders the Exclusion of Evidence Citing “Serious” and “Systemic” Breaches of the Canadian Charter of Rights and...

In the Bouchard case rendered in July 2023, many years after the Supreme Court of Canada rendered the Jarvis decision, the Court of Québec concluded that the fundamental rights of medical specialists (i) against...more

Goodwin

Common FDA Bioresearch Monitoring Violations: Updates from FY 2022 to Now

Goodwin on

The Bioresearch Monitoring (BIMO) Program, operated by the U.S. Food and Drug Administration (FDA), conducts on-site inspections and data audits in order to effectively monitor the compliance of all FDA-regulated research....more

Benesch

Are You Prepared for the End of the COVID-19 Form I-9 Flexibilities?

Benesch on

The Form I-9 flexibilities implemented during the COVID-19 Pandemic that permitted employers to virtually review Section 1 and inspect documents establishing identity and authorization to work are ending on July 31, 2023....more

WilmerHale

PCAOB Releases New Audit Committee Resource

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The PCAOB recently released a new Audit Committee Resource, which sets forth questions that audit committee members may want to consider incorporating into their ongoing engagement with auditors. The categories of questions...more

Oberheiden P.C.

6 FDA Audit Defense Strategies

Oberheiden P.C. on

An audit by the Food and Drug Administration (FDA) can uncover violations of federal food and drug regulations, as well as the Food, Drug, and Cosmetic Act (FD&C Act). Those violations can lead to administrative, civil, or...more

Vicente LLP

Environment, Health & Safety (EHS) Audit: What Cannabis Businesses Should Do After the Audit

Vicente LLP on

Environmental, Health, and Safety (EHS) audits can come in many varieties: regulatory agency inspections (scheduled or surprise), internal company requirements, maintenance of certifications, or during an acquisition or sale....more

Vicente LLP

Environment, Health & Safety (EHS) Audit: Tips for Cannabis Businesses on Audit Day

Vicente LLP on

Environmental, Health, and Safety (EHS) audits can come in many varieties: regulatory agency inspections (scheduled or surprise), internal company requirements, maintenance of certifications, or during an acquisition or sale....more

WilmerHale

Update on Recent Developments Ahead of FY21 Reporting Season

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As year-end fast approaches, there has been no shortage of regulatory developments relevant to the upcoming financial reporting season. Several of these developments are summarized below....more

Oberheiden P.C.

FDA Inspection Audit? What to Expect

Oberheiden P.C. on

The Food and Drug Administration is the federal agency charged with ensuring the safety of food, medication and other consumable products. In carrying out its duties, the FDA conducts both inspections of plants and...more

Fox Rothschild LLP

In A Fight Over Corporate Inspection Rights, A Quick Kick Beats The Trick Play

Fox Rothschild LLP on

A group of mostly powerless Class B members in a utility services firm suspected its only Class A member of self-dealing, but their suspicions did not mate with corporate authority to do much about it. However, blessed with...more

Arnall Golden Gregory LLP

Quality Agreements: An AGG Podcast Recap

A few weeks ago, AGG’s Food and Drug Practice Team launched its podcast series to discuss topics affecting the FDA-regulated industry. The series, called “I Wish I Knew What I Know Now: Conversations with AGG on FDA Issues,”...more

ArentFox Schiff

New Executive Order & Information Sharing Practices Increase Inspections of Federal Contractors’ Use of Temporary Foreign Workers...

ArentFox Schiff on

On August 3, 2020, President Trump signed an Executive Order requiring each executive department and federal agency to review the performance of contracts and subcontracts awarded in fiscal years 2018 and 2019 to determine...more

Mayer Brown Free Writings + Perspectives

SEC Staff Roundtable on Emerging Markets: Highlights from the Panel on Limitations on Inspection and Enforcement in Emerging...

On July 9, 2020, SEC Chief Accountant Sagar Teotia and SEC Division of Enforcement Co-Director Stephanie Avakian moderated a panel discussion concerning limitations on inspection and enforcement in emerging markets, and...more

WilmerHale

Sixth-Annual CAQ Audit Committee Transparency Barometer Shows Mixed Trends in Voluntary, Enhanced Audit Committee Disclosures

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Earlier this month, the Center for Audit Quality (CAQ) and Audit Analytics released their sixth-annual Audit Committee Transparency Barometer report.  Similar to prior years, the groups acknowledge “progress on the...more

Fisher Phillips

Breaking The ICE: How Employers Can Push Back Against Punitive I-9 Fines

Fisher Phillips on

Climate change may make our summers hotter, but the ICEman still cometh. Since late 2017, Immigration and Customs Enforcement (ICE) has significantly increased the number of Notices of Inspections issued to employers...more

Seyfarth Shaw LLP

ICE Chills the Summer with Thousands of Audit Notices Issued to Businesses Nationwide

Seyfarth Shaw LLP on

Seyfarth Synopsis: The temperature may be heating up in the nation’s capital, but Immigration and Customs Enforcement (ICE) is keeping things cool. ICE Acting Director, Matthew Albence, confirmed that almost 33301 Notices of...more

Ogletree, Deakins, Nash, Smoak & Stewart,...

Oregon Requires Employers to Provide Notice to Employees Prior to I-9 Inspections

A new Oregon law will require employers to notify their employees when they (the employers) are contacted by a federal agency that intends to audit, among other things, employer records and employment eligibility...more

Akin Gump Strauss Hauer & Feld LLP

PCAOB Issues 2019 Staff Inspections Outlook For Audit Committees As Part Of Its Outreach

As part of its transparency and outreach initiative to its stakeholders, the Public Company Accounting Oversight Board (“PCAOB” or “Board”) continues to issue staff briefs to better inform the public about how the Board is...more

Stinson LLP

The PCAOB Wants to Talk to the Audit Committee Chair—Now What?

Stinson LLP on

The Public Company Accounting Oversight Board (PCAOB) recently noted that it will provide an opportunity for audit committee chairs of certain companies whose audits are subject to inspection to “engage in a dialogue with the...more

Stinson - Corporate & Securities Law Blog

The PCAOB Wants to Talk to the Audit Committee Chair – Now What?

The PCAOB recently noted that during 2019 it will provide an opportunity for audit committee chairs of certain companies whose audits are subject to inspection to “engage in a dialogue with the inspections staff.” ...more

WilmerHale

PCAOB Issues 2019 Staff Inspections Outlook for Audit Committees

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On March 14, 2019, the Public Company Accounting Oversight Board issued its 2019 Staff Inspections Outlook for Audit Committees (the “Committee Outlook”), which offers a concise outline of what audit committees should expect...more

Stinson - Corporate & Securities Law Blog

PCAOB Posts 2019 Staff Inspections Outlook for Audit Committees

In a published document, the PCAOB noted its new strategic plan anticipated enhanced external engagement and more proactive communication with its stakeholders, including audit committees, to inform them about its core...more

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