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The investigator found that Orchid Orthopedic failed to regularly analyze rework shop orders as a source of quality data to identify potentially recurring quality problems. Read More
“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. Read More
Although the firm identified the possible root cause as being either a design, manufacturing or unknown issue, it did not initiate a CAPA or supplier corrective action. Read More