U.S. marshals seized all the dental devices from a Fla.-based company after a Food & Drug Administration inspection turned up violations in the company’s manufacturing processes.
Acting under court order from the FDA, the marshals on Jan. 5 and 6 removed the products from Hialeah, Fla.-based Rite-Dent Manufacturing Corp., according to the watchdog agency. The seized property is valued at valued at $208,910, the agency said.
During a Nov. 2010 inspection of the Rite-Dent facility the FDA found "continuing significant deviations from the current good manufacturing practice requirements for the products" The regulatory body previously warned the company about the violations that precipitated the visit from the federal agents during an inspection in 2005, and two more in 2010, according to the agency.
The agency’s November inspection also revealed that Rite-Dent had not obtained FDA clearance for the Ultra Impression System, and that the company failed to notify the agency about a correction it made to another device called the Alginate Impression System, according to the agency.
The seized dental products include Alginate Impression Material, Ultra Impression Material, Enamel Bonding System, Pit and Fissure Chemical Curing Sealant, Tooth Shade Resin Material, Cavity Varnish, Polycarboxylate (PCA) Cement and Zinc Phosphate Cement, the FDA said.
The FDA advises health care professionals to discontinue use of these products.