FDA Finds Integra’s CAPA, Design Transfer Procedures Inadequate

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.

Design transfer procedures weren’t implemented to ensure that device’s design specifications were correctly translated to production specifications through product testing, the agency said.

The agency said the devicemaker needed to establish and validate specifications to prevent breakage of a component during use.