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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 Conform to Current Good Manufacturing Practices (Patient Monitors)

An investigation in March 1999 revealed “a serious regulatory problem involving software for [the] Solar Model 7000/8000 Patient Monitors.” The “inspection found that the devices are adulterated within the meaning of Section 501 (h) of the Act in that the methods used in, facilities or controls used for manufacturing, packing, storage, or installation of the medical devices are not in conformance with the Good Manufacturing Practices (GMP) requirements set forth in the Quality System Regulations for Medical Devices as prescribed by Title 21, Code of Federal Regulations (CFR), Part 820. Violations included “failure to establish the appropriate responsibility, authority, and interrelation of all personnel who manage, perform, and assess work affecting quality” and “failure to establish and maintain procedures for validating the device design.”

Misconduct Type
Consumer Affairs
Enforcement Agency
Health and Human Services
Contracting Party
None
Court Type
Administrative
Disposition
Investigative Finding
Date of Investigation Report
4/9/1999
Contractors Involved Penalty
Total
General Electric $0
Further Information Released
FDA Warning Letter 8/29/2006

Federal Contractor Misconduct Database