FDA WARNING_LETTER - Gyrus ACMI, Inc. - August 02, 2012

On September 10, 2012, the FDA issued a Warning Letter to Olympus Gyrus ACMI, Inc. following an inspection from July 10 to August 2, 2012, at their Stamford, CT facility. The inspection revealed that the firm, a medical device manufacturer including the DUR-D Ureteroscope, was not in conformity with Current Good Manufacturing Practice (CGMP) requirements of the Quality System (QS) regulation (21 CFR Part 820), rendering their devices adulterated under section 501(h) of the Act.

The FDA deemed the firm's August 22, 2012, response to the Form FDA 483 inadequate. Key violations included:

1. **Failure to conduct design validation (21 CFR 820.30(g)):** The firm lacked data to demonstrate the DUR-D ureteroscope shaft was tested for bending and torque under actual use conditions to prevent kinking, despite a 2006 FMEA identifying this as a potential problem. The firm's claim of 2010 process enhancements was not supported by documentation of effectiveness. 2. **Failure to establish and maintain complaint procedures (21 CFR 820.198(a)(3)):** The complaint procedure lacked detailed information for Medical Device Reporting (MDR) assessments. For multiple complaints, the firm