Grimy Times has uncovered a shocking tale of corruption in the medical device industry. Invacare Corp, a wheelchair manufacturer based in Elyria, Ohio, has agreed to a consent decree with the federal government to resolve allegations of violating the Food, Drug and Cosmetic Act (FDCA).
The complaint and proposed consent decree were filed in the U.S. District Court for the Northern District of Ohio, at the request of the Food and Drug Administration (FDA), due to numerous allegations of violations of the Food, Drug and Cosmetic Act (FDCA).
The FDA conducted multiple inspections of Invacare’s corporate headquarters and Taylor Street manufacturing facility, both located in Elyria, Ohio, between September 2002 and August 2011. Those inspections revealed significant violations of the Current Good Manufacturing Practices (CGMP) regulatory requirements.
“Today’s proposed consent decree would require Invacare to establish procedures that will help ensure their products are safe and effective for the patients who rely on them,” said Stuart F. Delery, Principal Deputy Assistant Attorney General for the Civil Division of the Justice Department.
“This resolution underscores the commitment of our office and this department to protecting consumers, particularly those who have to use wheelchairs or hospital beds,” said Steven M. Dettelbach, U.S. Attorney for the Northern District of Ohio.
The matter was handled by the Justice Department’s Consumer Protection Branch, the FDA’s Office of the General Counsel, and the U.S. Attorney’s Office for the Northern District of Ohio.
Under the terms of the agreement reached with the government, the defendants cannot resume manufacturing power wheelchairs or conducting design activities related to wheelchairs and power beds at the two Ohio facilities until an independent expert inspects the company’s operations and certifies that the defendants are in compliance with the law.
Until FDA provides written notification that the facilities are in compliance with the law, they cannot resume operations.
Defendant: Invacare Corp
Criminal Charges: Violations of the Food, Drug and Cosmetic Act (FDCA)
City and State: Elyria, Ohio
Exact Date: September 2002 – August 2011 (inspection period)
Sentence or Outcome: Consent decree with conditions
Dollar Amounts: Not applicable
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Key Facts
- State: Ohio
- Category: White Collar Crime
- Source: DOJ Press Release â†â€â€
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