Dental Device Distributor Lacks Written Procedures, FDA Says

Premium Dental, a bite tray importer and distributor, received a warning letter for lack of complaint handling, medical device reporting (MDR) and corrective and preventive action (CAPA) procedures.

The Brick, N.J.-based company has no procedures to receive, document and process complaints, or to evaluate them for MDR reportability, according to the Jan. 14 letter posted to the FDA website this month.

Premium Dental’s response to this citation on the Form 483 appears adequate, the FDA says in the warning letter, but its implementation needs to be verified.

The letter, which stems from a July 29 to Aug. 5 inspection, also cites the company for failure to develop and implement written MDR procedures. The FDA considers Premium Dental’s Form 483 response on this issue inadequate because its procedures do not describe how the company will:

  • Include all required information in reports to be submitted to the FDA;
  • Determine when an event meets the criteria for reporting an event to the agency;
  • Conduct a complete investigation of each event to determine the cause;
  • Submit supplemental reports to the agency within the required time frames; and
  • Document and maintain records.

A section on reports of corrections and removals in Premium Dental’s MDR document refers staff to the FDA’s reporting requirements when a “risk to health” determination is made. Merely referencing the regulation in a standard operating procedure is not adequate, the agency says, because there is no way to verify its effective implementation.

Premium Dental also failed to establish procedures to implement CAPAs, according to the FDA. The company’s Form 483 response to this issue is inadequate because its proposed CAPA procedure does not specify how the company will verify or validate CAPAs to ensure they are effective, the agency adds. For example, Premium needs to perform effectiveness checks to verify that CAPAs are effective and that new issues are not introduced.

Further, the response did not include training records to show the CAPA procedures are implemented and are being followed.

The devices Premium Dental handles have not been approved or cleared, are not manufactured at an FDA-registered facility and are not listed with the agency, according to the letter.

The company did not respond to a request for comment by press time.

The warning letter is available at — April Hollis