The QMN Weekly Bulletin
Quality / Medical Devices

483 Roundup: FDA Cites Firms Over Complaint Handling, Other Deficiencies

June 16, 2017
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The FDA cited device manufacturer US Vascular for a wide range of deficiencies, including inadequate procedures for handling complaints.

Following an April inspection of the firm’s Beaverton, Ore., facility, the FDA issued a Form 483 with 14 observations.

Inspectors found at least six complaints the firm failed to evaluate to see if they required further investigation or reporting to the FDA as an MDR.

The agency also faulted the device manufacturer on its design history file for its diagnostic devices, which failed to include documentation of design verification or validation.

The FDA also cited the facility’s controls for non-conforming products. The company failed to segregate the products, and to document investigations, risk assessments and further actions before retesting.

Inspectors further noted that the firm had not established a required audit schedule or conducted an internal audit as of April 11, 2017. The facility also lacked adequate corrective and preventive action procedures.

Kronner Prototypes: The FDA cited Kronner Prototypes for its complaint handling, reporting procedures and quality issues, following an April inspection of the devicemaker’s Roseburg, Ore., facility.

The agency issued a Form 483 noting the firm had three different, often contradictory, complaint handling procedures. Several complaints failed to include an evaluation of whether they should be reported to the FDA — and the company had no written MDR procedures.

The company also failed to document verification or validation of corrective actions taken in response to two complaints, and it did not properly implement procedures for measuring instrument calibration, the agency said. Other deficiencies included incomplete checklists for finished device acceptance.

The firm had also failed to document any quality audits since the previous FDA inspection in April 2014.

Pulsar Vascular: The FDA faulted device manufacturer Pulsar Vascular for its process validation and design control procedures.

The agency issued a Form 483 following a February/March inspection of the company’s Los Gatos, Calif., facility. According to the FDA, Pulsar’s master process validation plan inaccurately stated several in-house processes required validation and revalidation. The agency requested validation and revalidation records for all processes inaccurately documented as requiring both processes, but was told none.

Inspectors also observed deficiencies in the design history file for Pulsar’s PulseRider aneurysm neck reconstruction device. The file did not clearly define planned design phases and formal design reviews, and the reviews failed to include a reviewer without direct responsibility for the design stage in question.

Tena Group: The FDA slammed hearing aid manufacturer Tena Group for its quality systems and audit procedures.

The agency issued a Form 483 following a June 2016 inspection of Tena’s Windham, Maine, facility. According to inspectors, the firm created a quality manual and quality policy in 2011 but failed to apply it throughout the organization.

In addition, the facility had an internal audit procedure, but could not provide evidence that any quality system audits had been conducted. Inspectors also found no documentation of non-conforming products, and no evidence that the facility conducted internal audits or recorded service repairs that would require a corrective and preventive action plan. The facility also lacked written procedures for medical device reports and complaint reviews.

The companies did not respond to requests for comment.

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