Failure to Validate Processes Results in FDA Warning

The FDA has sent a warning letter to Tokyo-based Fuji System because the company allegedly failed to validate its processes for silicone tubing extrusion and vulcanization of its intubation devices, Sibroncho and USA Uniblocker, and Phycon Silicone Foley balloon catheters.

“Some processes have not been validated and others have not been adequately validated according to established procedures,” the FDA’s letter said.

In its letter, the FDA said Fuji System’s package-sealing process lacked established pressure limits, and the company’s corrective and preventative action (CAPA) procedures did not include provisions to verify or validate the effect and impact of the CAPA.

“[Your] response did not address any retrospective review of other processes that may need process validation or a review of other completed process validations for assurance of its completeness,” the letter said.