April 4, 2018: Fences Indicted in Multi-Million Dollar, Multi-State Criminal Theft Operations

  Food and Drug Administration Office of Criminal Investigations   HOUSTON – Two brothers are set to appear in court following the return of two indictments for their separate operations involving the possession and interstate transportation of stolen property, announced U.S. Attorney Ryan K. Patrick. A federal grand jury returned the indictments March 28, 2018, against…

April 4, 2018: Canadian Pharmacist Sentenced for Distributing Counterfeit and Adulterated Botox to Local Doctors

      Food and Drug Administration Office of Criminal Investigations   St. Louis, MO – Nikhil Buhecha, a resident of Vancouver, British Columbia, Canada, pled guilty today and was sentenced to 36 months’ imprisonment for conspiring to distribute counterfeit, misbranded, and adulterated Botox® into the United States, including multiple shipments to two doctors located in St….

March 27, 2018: Federal Jury Finds Three Guilty in Fentanyl Distribution Conspiracy

  Food and Drug Administration Office of Criminal Investigations    Massive Overdose Outbreak in Murfreesboro Left One Person Dead and More than 20 Hospitalized A federal jury in Nashville, Tennessee yesterday, returned guilty verdicts against three individuals on trial for their role in a deadly fentanyl distribution conspiracy, announced U.S. Attorney Don Cochran of the Middle…

Certain Prescription Insomnia Medicines: New Boxed Warning – Due to Risk of Serious Injuries Caused by Sleepwalking, Sleep Driving and Engaging in Other Activities While Not Fully Awake

[Posted 04/30/2019] AUDIENCE: Patient, Health Professional, Pharmacy ISSUE: FDA is advising that rare but serious injuries have happened with certain common prescription insomnia medicines because of sleep behaviors, including sleepwalking, sleep driving, and engaging in other activities while not fully awake. These complex sleep behaviors have also resulted in deaths. These behaviors appear to be more…

About Warning and Close-Out Letters

This page reviews the types of warning letters found on the FDA website. General FDA Warning Letters When FDA finds that a manufacturer has significantly violated FDA regulations, FDA notifies the manufacturer. This notification is often in the form of a Warning Letter. The Warning Letter identifies the violation, such as poor manufacturing practices, problems…

Inspection Citation

On January 21, 2009, President Obama issued the Open Government Initiative. These data sets were created to provide public information regarding the various findings that result from inspections. The Agency is disclosing findings from these inspections to improve the public’s understanding of how the FDA works to protect the public health, provide the public with…

Inspection Classification Definitions

At the end of an inspection, observations made during an inspection are shared with the most responsible party at the firm in an FDA Form 483, Report of Observations. The determination of whether any condition or practice is violative is an Agency decision, made considering all inspectional and compliance input. An inspection classification may be…

FSVP and Produce Inspections

When Will FSVP Inspections of Produce Importers Begin? In the Foreign Supplier Verification Programs (FSVP) regulation, compliance dates are set up so that, for many importers, compliance dates are linked to when the foreign supplier must meet the requirements of the new FDA Food Safety Modernization Act rules (specifically, when the foreign supplier must meet…

Produce Safety Inspections

The FDA and National Association of State Departments of Agriculture (NASDA) and our state partners have collaborated to develop two new documents to be used in support of produce inspections. Form 4056 (Produce Farm Inspection Observations) The first document is the Form FDA 4056, “Produce Farm Inspection Observations.” This form represents a new way of…