The QMN Weekly Bulletin

FDA Warns Euromi Over Complaint Handling

Oct. 2, 2015

Belgium-based Euromi was slapped with a far-ranging FDA warning letter that chides the company for not properly handling complaints, including instances in which cannula tips from a liposuction system broke and became lodged in patients.

During an inspection of Euromi’s Verviers, Belgium, facility that took place Jan. 12 through 15, an FDA investigator determined the company had failed to establish procedures for reviewing complaints related to the EVA Sp liposuction system to ensure they are analyzed in a timely manner.

The company also neglected to document oral complaints upon receipt, ensure that complaint investigation records contained all required information, explain why the company in some instances didn’t investigate a complaint, and ascertain whether complaints were evaluated for MDR reportability. That final citation extended to events in which cannulae broke, and fragments remained in patients.

Lacking MDR Procedures

Also, the company didn’t establish internal systems for the timely transmission of complete MDRs, including no instructions for obtaining and completing an FDA 3500A form.

Euromi also didn’t have a description of how the company will address documentation and recordkeeping requirements, including documentation of adverse-event related information and deliberations used to determine if a device-related death, serious injury or malfunction was reportable or not.

The company also was cited for not establishing procedures to ensure that all received products conform to specified requirements. For example, it didn’t ensure that its contract sterilizer validated the sterilization of a disposable tubing set used with the EVA Sp6 liposuction device.

The FDA also hit the company for its corrective and preventive actions procedure, saying it doesn’t include requirements for analyzing data to ascertain existing and potential causes of nonconforming product or other quality problems.

“The CAPA file for nonconformance 108 (for bending problems on 2.0 mm and 2.5 mm infiltration cannulas), did not identify the batch records of the device used for testing,” the agency writes. In addition, the company failed to verify and validate the effectiveness of its corrective actions.

In addition, the company was cited for failing to ensure that all inspection, measuring and testing equipment is suitable for the intended purposes. For example, the tester used to analyze cannula flow contained measuring devices that haven’t been calibrated to ensure the equipment is capable of producing valid results.

Obsolete Documents, Audit Problems

The FDA also took the company to task for not having proper measures in place for document control to ensure outdated documents are removed to prevent unintended use. It also failed to obtain approval dates and signatures to ensure the documents were removed.

Audit issues also appear in the warning letter. The company’s quality audit procedures don’t define what quality system areas should be audited and don’t ensure that auditors are independent of the areas being evaluated.

Although the company submitted a response on April 29 to a Form 483, the agency didn’t review it, as it wasn’t received within the required 15 business days.

The FDA also said it was “taking steps to refuse entry of these devices into the United States” until the violations have been corrected.

The company did not respond to a request for comment.

CAPA violations and failing to follow FDA protocols when dealing with and processing complaints are the two easiest ways to get a warning letter. Stay out of trouble by ordering our management report Medical Device Complaint Management: A Guide for Compliance, which spells the do’s and don’ts of effective device complaint management!