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Medical Devices / Inspections and Audits

Fetal Monitor Manufacturer Cited by FDA for Documentation

Nov. 8, 2019

A fetal monitoring system manufacturer in Cary, North Carolina was hit with a Form 483 inspection report for various issues, including failure to document acceptance activities and required complaint investigation information.

The FDA cited WatchChild for inadequate complaint investigations following its review of the firm’s records, which did not include root causes and an identification of how or if the patients were impacted.

The company also failed to document and maintain acceptance activities as part of the device history record. The firm also didn’t have documents to show it performed incoming acceptance steps.

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