FDANews
The QMN Weekly Bulletin

Fuji System Gets Warning Letter for Not Validating Processes

Dec. 26, 2008
Tokyo-based Fuji System failed to validate its processes for silicone tubing extrusion and vulcanization of its intubation devices, Silbroncho and USA Uniblocker, and for its Phycon Silicone Foley balloon catheters, according to an FDA warning letter.

The company’s package sealing process lacks established pressure limits, and Fuji’s corrective and preventive action (CAPA) procedures did not include provisions to verify or validate the effect and impact of the CAPA, the letter says.

According to the Aug. 18 warning letter, which was posted recently to the FDA website, “When procedures are submitted in response to this deficiency, the portion relating to correcting this observation should be translated into English,” the letter says.
The GMP Letter