Fuji System Gets Warning Letter for Not Validating Processes

A warning letter from the FDA has cited Tokyo, Japan-based Fuji System for not validating its processes for silicone tubing extrusion and vulcanization of two of its intubation devices, Silbroncho and USA Uniblocker, and for its Phycon Silicone Foley balloon catheters. 

The letter says the company’s package sealing process lacks established pressure limits, and Fuji’s corrective and preventive action (CPA) procedures did not include provisions to verify or validate the effect and impact of the CAPA, the letter says.
 
According to the letter, which was posted recently to the FDA Web site, “When procedures are submitted in response to this deficiency, the portion relating to correcting this observation should be translated into English,” the letter says. 

To view the warning letter, go to www.fda.gov/foi/warning_letters/s7018c.htm.