Food and Drug Administration Office of Criminal Investigations   BOSTON – A Lynn man was sentenced yesterday in federal court in Boston for his role in a conspiracy to traffic counterfeit steroids, including testosterone and trenbolone, to customers across the country. Philip Goodwin, 37, was sentenced by U.S. District Court Judge Nathaniel M. Gorton to…

  Food and Drug Administration Office of Criminal Investigations   KANSAS CITY, Mo. – A Kansas City, Mo., Fire Department paramedic has been indicted by a federal grand jury for stealing fentanyl and morphine from ambulances and replacing fentanyl with another substance. Michael L. Fostich, 36, of Kansas City, Mo., was charged in a two-count indictment…

      Food and Drug Administration Office of Criminal Investigations   Benjamin G. Greenberg. United States Attorney for the Southern District of Florida and Justin D. Green, Special Agent in Charge, U.S. Food & Drug Administration, Office of Criminal Investigations (FDA OCI), Miami Field Office, made the announcement. Flores previously pled guilty to participating in a…

  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…

      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….

  Food and Drug Administration Office of Criminal Investigations   BIRMINGHAM – A federal judge today sentenced the owner of a Decatur compounding pharmacy to five years in prison for conspiring to defraud a federal health insurance program out of more than $10 million. U.S. Attorney Jay E. Town, Food and Drug Administration, Office of Criminal…

  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…

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…

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…

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…