Company cited for significant manufacturing violations
SILVER SPRING, Md., Jan. 13, 2011 /PRNewswire-USNewswire/ -- U.S. Marshals, acting under a court order sought by the U.S. Food and Drug Administration, on Jan. 5 and 6, seized all dental devices from Rite-Dent Manufacturing Corporation, located in Hialeah, Fla.
The seizure of dentistry products valued at $208,910 follows an FDA inspection that found significant deficiencies in the company's manufacturing processes that may affect the safety and effectiveness of the products.
The seized 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, all used in the practice of dentistry. FDA inspections of the Rite-Dent facility, most recently in November 2010, revealed continuing significant deviations from the current good manufacturing practice requirements for the products. Good manufacturing practice requirements help to ensure the safety and effectiveness of medical devices.
FDA's recent inspection also confirmed that the company had not obtained FDA marketing approval or clearance for a device called the Ultra Impression System.
The company also failed to notify the FDA regarding a correction it made to a device called the Alginate Impression System.
The FDA previously warned the company about these and similar violations during FDA inspections in 2005, March 2010, and May-June 2010, as well as in a 2005 Warning Letter.
The FDA advises health care professionals to discontinue use of these products.
"The FDA expects medical device producers to follow good manufacturing practice and to obtain clearance or approval of the devices that they market," said Jeffrey Shuren, M.D., Director of FDA's Center for Devices and Radiological Health. "If firms ignore these requirements, we will take appropriate action to protect public health."
For more information:
- FDA Warning Letter to Rite-Dent Manufacturing Corp., December 2, 2005 http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2005/ucm075724.htm
SOURCE U.S. Food and Drug Administration