FDAnews Device Daily Bulletin
Medical Devices / Inspections and Audits

Valtronic Falls Short on CAPAs

April 4, 2019

Contract device manufacturer Valtronic netted a Form 483 for inadequate CAPA procedures, nonconforming products and a failure to document validations at its Solon, Ohio plant.

The FDA inspected the facility from Dec. 12-19, 2018 and found that Valtronic was not analyzing nonconformance data for potential corrective and preventive actions as a quality data source for its CAPA system or analyzing the data.

At least two CAPAs were opened in 2017 to address delamination issues, but they were not completed and did not address the investigative activities. One was closed as “unsuccessful,” while the other had no further action taken.

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