News & Analysis as of

Office of the Inspector General Inspections

Holland & Knight LLP

FDA Warning Letter Marks Significant Shift in Enforcement of Laboratory Developed Tests

Holland & Knight LLP on

The U.S. Food and Drug Administration's (FDA) March 21, 2024, warning letter to Agena Bioscience Inc. (Agena), a genetic diagnostic test developer, generated a lot of immediate commentary among regulatory lawyers and...more

Fox Rothschild LLP

Animal Exhibitor Alert: Follow-Up to Animal and Plant Health Inspection Service’s (APHIS) Controls Over Licensing of Animal...

Fox Rothschild LLP on

According to the USDA OIG Audit Report 33601-0003-23, previously available online, APHIS Animal Care (AC) had agreed that it would review barrier issues and may require reporting of escapes and attacks. However, Audit Report...more

Morgan Lewis - Up & Atom

NRC Receives Passing Grade from OIG on COVID-19 Adaptations to Inspections

The NRC’s Office of the Inspector General (OIG) recently released a report (OIG-21-A-13) discussing the results of its audit of the NRC’s pandemic oversight of nuclear power plants. The purpose of the audit was to “assess the...more

Bass, Berry & Sims PLC

HHS OIG Releases Five Work Plan Updates Related to COVID-19

Bass, Berry & Sims PLC on

On March 23, the Department of Health and Human Services (HHS) Office of Inspector General (OIG) updated its Work Plan in response to the COVID-19 pandemic. The OIG Work Plan sets forth planned or ongoing agency evaluations,...more

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

Superfund Site Visits - Verification of the Effectiveness of Institutional Controls: U.S. EPA office of Inspector General Project...

The United States Environmental Protection Agency (“EPA”) Office of Inspector General (“OIG”) issued a project notification dated September 20th titled: Superfund Site Visits – Verification of the Effectiveness of...more

Arnall Golden Gregory LLP

The OIG Applauds FDA’s Progress in Inspections of Generic Drug Manufacturers but Recommends More to be Done

The Department of Health and Human Services’ Office of Inspector General has recently recommended that the Food and Drug Administration continue to increase its pre-approval inspections of generic drug companies. The OIG...more

Bergeson & Campbell, P.C.

Inspector General Launches Investigation into EPA's RCRA Inspections

EPA’s Office of Inspector General (OIG) has launched an investigation to determine whether EPA is inspecting hazardous waste treatment, storage and disposal facilities (TSDFs) in compliance with the law....more

Mintz - Immigration Viewpoints

USCIS Rolls Out Full-Scale Implementation of L-1 Site Visit Program: Employers of L-1 Transferees Should Now Set up Processes to...

U.S. Citizenship and Immigration Services’ (USCIS) Fraud Detection and National Security (FDNS) Directorate has recently begun implementation of an L-1 site inspection program in response to an August 2013 report released by...more

Proskauer Rose LLP

USCIS Site Visits – Expanding to L-1 Petitioners

Proskauer Rose LLP on

The United States Citizenship and Immigration Service (USCIS) created and implemented the Administrative Site Visit and Verification Program (ASVVP) in July 2009, under which it conducts unannounced site inspections at the...more

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