The U.S. Food and Drug Administration (FDA) is advising healthcare professionals to discontinue using products manufactured by Rite-Dent Manufacturing after U.S. marshals seized all dental products from the company's facility in Florida on January 5 and 6.
The marshals were acting under a court order sought by the FDA, which has issued numerous warnings to the company for more than five years.
The seizure of products, valued at $208,910, was prompted by the agency's most recent inspection of the Rite-Dent facility, which found "significant deficiencies" in the company's manufacturing processes that may affect the safety and effectiveness of the products, the FDA noted in a press release.
The seized products were both raw materials and finished products, including Alginate Impression System (including Alginate Regular Mint, Alginate Fast Mint, Alginate Slow Mint, and Alginate Regular Mint Dustless), Ultra Impression System, Rite-Copal Varnish, Chemical Cure Enamel Bonding System, Pit & Fissure Light Curing Sealant, Pit & Fissure Chemical Curing Sealant, New Improved Zinc Phosphate Cement (liquid and powder), and Polycarboxylate Cement (liquid and powder).
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, the FDA noted.
The agency's most recent inspection also confirmed that Rite-Dent had not obtained FDA marketing approval or clearance for the Ultra Impression System and had failed to notify the FDA regarding a correction it made to the Alginate Impression System.
The agency 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 expects medical device producers to follow good manufacturing practice and to obtain clearance or approval of the devices that they market," said Jeffrey Shuren, MD, JD, director of the FDA's Center for Devices and Radiological Health. "If firms ignore these requirements, we will take appropriate action to protect public health."
When contacted by DrBicuspid.com, Cesar Veliz, vice president of Rite-Dent, said the company may issue a statement about the case in the next day or so.
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