FDA WARNING_LETTER - Guidewire Technologies, Inc. - January 22, 2010

On February 26, 2010, the FDA issued a Warning Letter to Guidewire Technologies, Inc. following an inspection from January 12-22, 2010, which found their guidewire products to be adulterated. The firm's manufacturing, packing, storage, or installation methods and controls did not conform to the Quality System (QS) regulation (21 CFR Part 820).

The FDA reviewed the firm's February 11, 2010 response to the Form FDA 483 but found it lacked documentation and evidence of implemented corrective actions. Key violations include:

1. **Failure to establish procedures for finished product acceptance criteria (21 CFR 820.80(d)):** Specifically, (b)(4) testing is not conducted after each sterilization process for sterile packed guidewires, despite the 510(k) submission stating finished Teflon-coated guidewires would be (b)(4) free. 2. **Failure to validate processes (21 CFR 820.75(a)):** The Teflon guidewire coating process has not been validated. Additionally, the (b)(4) system installed in April 2008 lacks validation data, and no product bioburden testing has been performed since 2006. 3. **Failure to conduct quality audits (21 CFR