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Federal Contractor Misconduct Database (FCMD)

The federal government routinely awards contracts to companies with histories of misconduct, including contract fraud and other violations. POGO believes that providing this website will help to improve contracting decisions and increase public knowledge of how the government spends billions of taxpayer dollars each year. Read more…

Failure to Investigate EpiPen Failures

The Food and Drug Administration (FDA) issued a warning letter to Pfizer’s Meridian Medical Technologies (MMT) division regarding “significant violations of current good manufacturing practice requirements” at its Brentwood, Missouri facility. During an inspection of the facility in February and March 2017, FDA found MMT “failed to thoroughly investigate multiple serious component and product failures” relating to the EpiPen auto-injecting device, “including failures associated with patient deaths and severe illness,” and also failed to expand the scope of its investigations “into these serious and life-threatening failures or take appropriate corrective actions.” The FDA found MMT received hundreds of complaints that EpiPens failed to operate during life-threatening emergencies, but did not thoroughly investigate these complaints or remove potentially defective EpiPens from the marketplace. The FDA also determined that MMT’s procedures for handling complaints were inadequate.

Misconduct Type
Health
Enforcement Agency
Health and Human Services
Contracting Party
None
Court Type
N/A
Disposition
Investigative Finding
Date of Warning Letter
9/5/2017
Contractors Involved Penalty
Total
Pfizer, Inc. $0
Further Information Released
FDA Warning Letter 9/5/2017

Federal Contractor Misconduct Database