FDA WARNING_LETTER - Zevex International, Inc. - January 05, 2010

On December 7, 2010, the FDA inspected Zevex International, Inc., a subsidiary of MOOG, Inc., which manufactures Curlin 4000 and Curlin 6000 Infusion pump systems. The inspection revealed that these devices are adulterated because their manufacturing, packing, storage, or installation methods and controls do not conform to the Quality System (QS) regulation (21 CFR Part 820).

Key violations include: 1. **Failure to establish and maintain adequate procedures for corrective and preventive action (CAPA)** (21 CFR 820.100(a)). The CAPA procedure lacked definitions for "timely manner" and "all due haste," and several CAPAs remained open for extended periods. The procedure also failed to specify the use of statistical methodology for data analysis and did not require verification of corrective actions for recurring problems. The company's response was deemed inadequate as it lacked complete documentation and results of their action plan.

2. **Failure to establish and maintain adequate procedures for design changes** (21 CFR 820.30(i)). Software revisions for the Curlin 6000 infusion pump, intended to eliminate issues, were not adequately validated, leading to new problems. Servicing requirements were not identified or validated prior to implementation. A critical safety note in the User Manual was not updated on the firm's website. The response was inadequate due