U.S Marshals Seize Rite-Dent’s Dental Devices for Manufacturing Violations

• Date: January 19, 2011
• Source: Admin

On Jan 5 and 6, U.S. Marshals seized all dental devices from Rite-Dent Manufacturing Corporation, Hialeah, Fla. They acted under a court order sought by the US Food & Drug Administration (FDA). The seizure took place as the FDA, during inspection, found serious deficiencies in the company’s manufacturing processes. The deficiencies could affect the safety and effectiveness of the products.

Seized Products

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, all used in the practice of dentistry, are amongst the seized products.

Latest Inspection

During its Nov 2010 inspection, the FDA noticed that the company was not adhering to the current good manufacturing practice requirements. Strict adherence to good manufacturing practice requirements ensures the safety and effectiveness of medical devices. Also, the company had not obtained marketing approval from FDA for its Ultra Impression System. Incidentally, the FDA warned the company in 2005, March 2010 and May-June 2010 about these violations. It issued a Warning Letter to the company in 2005.

Regulations

The FDA is likely to revive a law that has been dormant since the 1980's, to send a strong signal to companies. The FDA gets its authority from the Park Doctrine, which allows it to seek criminal convictions for violations of the federal Food, Drug and Cosmetic Act against executives, even if they are unaware of specific manufacturing violations but are in a position of authority to prevent or correct the problems. Although the FDA is yet to bring any criminal charges against high-ranking executives, experts believe there are a lot of sleepless nights right now in the industry.

Sources:

http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm237894.htm

http://money.cnn.com/2010/08/23/news/companies/fda_recall_prosecutions/index.htm