The QMN Weekly Bulletin
Quality / Medical Devices

FDA Warns Company to Take Hint From Establishment Inspection

April 4, 2014

The FDA has warned Ultradent, a dental device manufacturer, for significant and repeated quality violations related to CAPAs, packaging, labeling and device design.

Several of the citations had been brought to the company’s attention during an earlier establishment inspection, according to the March 17 letter posted online Mar. 25. “It is our expectation that deviations from cGMP that are identified during establishment inspections, and of which your firm is provided formal notification through the issuance of a Form FDA 483, are not repeated,” the letter says. “Of more concern is that your firm is not always capable of identifying these quality issues as you appear to be notified through consumer complaints and FDA inspections.”

The letter notes that the South Jordan, Utah, company has hired a third-party consultant to review its quality system.

Among the citations was distributing devices “despite a general lack of cGMP in manufacturing the devices, including the failure to ensure appropriate design development.” Design verification for some products was conducted with prototype devices manufactured on unqualified equipment, the letter says. And clinical field testing for product validation was conducted with the prototype units and without clinical protocols.

Further, the company stated in a 510(k) that design validation for ceramic brackets was completed when it was not performed appropriately, the letter says. “Of more concern is that you were cited for this issue in the 2010 establishment inspection when you failed to appropriately validate VALO dental curing devices prior to release for sale.”

The company also failed to take effective corrective actions on potential systemic issues, including bonding problems with its Avex CX and CXi Ceramic Brackets and packaging and labeling issues affecting multiple product lines.

While Ultradent learned of the bonding issue in September 2011 and considered it safety-related, the company had not taken corrective action by the time of the FDA inspection, the warning letter says. It notes that the company conducted three recalls over the issue.

Investigators also looked at Ultradent’s complaint database, finding complaints with labeling and packaging mix-ups after closure of CAPAs. This “show[s] your practice of continued distribution of products not meeting specifications for packaging and labeling,” the letter says.

Meanwhile, the company did not ensure that all complaints are evaluated for MDR reportability.

“You have demonstrated a repeat failure to correct this issue as duplicate citations were issued to your firm in 2006 and 2010,” the FDA says. “During the current inspection, we observed that you continue to be deficient in obtaining complete complaint information to determine if an MDR is necessary. You also demonstrate repeat failure to consider that an injury does not necessarily have to occur for an event to be potentially reportable (events where there is no injury, but the device malfunctioned and would be likely to cause or contribute to a death or serious injury if the malfunction were to occur).”

The agency also chided Ultradent for failing to completely investigate complaints related to possible failure to meet specifications.

“Although this matter does not impede our ability to continue to supply our products, we take this matter seriously and are actively working with the FDA to resolve the issues expeditiously,” Dan Fischer, president and CEO of Ultradent, said.

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