Corrective actions by Integra Neurosciences may have affected the integrity of its external drainage systems and led to a cerebrospinal fluid leak, FDA inspectors found during an inspection of the firm’s Anasco, Puerto Rico plant.
The agency said the neurosurgical devicemaker needed to establish and validate specifications to prevent breakage of the stopcock component during use.
Design transfer procedures weren’t implemented to ensure that device design specifications were correctly translated to production specifications through product testing, the agency said.
In addition, the firm’s acceptance activities did not include quantifiable critical device specifications, and purchasing control procedures were inadequate to ensure that all products the firm received conformed to specifications.
Read the Integra Neurosciences Form 483 here: www.fdanews.com/12-06-19-integracincdbaintegranurosciencesprinc483.pdf.