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Medical Devices / Inspections and Audits

North Carolina Devicemaker Cited Over Design Controls

May 20, 2019

The FDA cited a Wilkesboro, North Carolina device manufacturer following a July 2018 inspection that revealed problems with the firm’s design control procedures.

Hinson and Hale Medical Technologies’ design control procedures didn’t define quality system requirements for design documents and records, the investigator found.

The agency said it needed the missing documentation to support a 510(k) marketing application. “The firm's missing design plans were necessary to ensure that the supporting device test records submitted with the 510(k) were complete and accurate,” the FDA said.

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