CGMP Violations Could Lead to Three Years in Jail for Former Medical Device Executive
The US Food and Drug Administration's (FDA) Office of Criminal Investigations and the US Department of Justice (DOJ) have announced the indictment of William Zinnanti, the former President and Owner of Zinnanti Surgical Design, for selling devices to hospitals in violations of current Good Manufacturing Practices (cGMPs).
According to a 15 May statement released by DOJ, Zinnanti Surgical Design manufactured a non-sterile surgical device used primarily in hospital settings to cut and suture tissue used around the thoracic vertebrae.
"The Information alleges that the surgical pencils were adulterated because the methods, facilities, and controls Zinnanti used for the manufacture, packing, and storage of the Bayonet Electro-Surgical Pencil did not comport with current good manufacturing practice to ensure that the devices were safe and effective and in compliance with the Federal Food, Drug, and Cosmetic Act," wrote DOJ in a press release.
"According to the charges in the Information, Zinnanti acted with the intent to defraud and mislead the FDA with regard to the manufacturing procedures he had in place," continued DOJ. "After questions surrounding the sterility of the device came to light in 2006, a nationwide and international recall was instituted."
In FDA's 2007 warning letter to Zinnanti, FDA noted serious deficiencies in the company compliance with cGMP and quality system regulations, in addition to a host of other problems.
Zinnanti faces up to three years in jail and a $250,000 fine if convicted of the charges. In remarks to The Patriot News, Zinnanti's lawyer, Alan Caplan, said Zinnanti hopes to plead guilty to the charge so he can avoid jail time and continue practicing medicine at Stanford University.
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FDA Warning Letter - Zinnanti Surgical Design, LLC 19-Sep-07