Fuji System Corp – FDA Warning Letter, Apr 9, 2008

On August 18, 2008, the FDA issued a Warning Letter to Fuji System Corp, Tokyo, Japan, following an inspection from April 7-9, 2008. The inspection determined that the firm manufactures the Silbroncho, USA Uniblocker, and Phycon Silicone Foley Balloon Catheter, which are considered adulterated devices under section 501(h) of the Federal Food, Drug, and Cosmetic Act. This is due to non-conformity with Current Good Manufacturing Practice (CGMP) requirements of the Quality System (QS) regulation (21 CFR Part 820).

The letter addresses the firm's May 14, 2008, response to the FDA 483 observations, deeming it inadequate for several violations:

1. **Failure to validate processes (21 CFR 820.75(a)):** The silicone tubing extrusion and vulcanization processes were not validated, and the package sealing process validation lacked established pressure limits. The firm's response was inadequate as it only confirmed the need for validation and provided a September 2008 correction date, without addressing retrospective review of other processes. 2. **Failure to establish and maintain adequate CAPA procedures (21 CFR 820.100(a)):** CAPA procedures did not include provisions to verify/validate the effectiveness of corrective/preventive actions and