FDA WARNING_LETTER - WalkMed Infusion, LLC - September 16, 2010

On September 7-16, 2010, an FDA inspection of WalkMed Infusion, LLC, a manufacturer of Class II electronic infusion pump systems, revealed adulterated devices due to non-conformity with Current Good Manufacturing Practice (CGMP) requirements of the Quality System (QS) regulation (21 C.F.R. Part 820).

Significant deviations included: 1. **Failure to investigate complaints (21 C.F.R. 820.198(c))**: The firm did not investigate complaints of severe under-delivery to determine medical intervention or patient outcome for MDR reportability. Complaint questionnaires for alarm failures were incomplete, with no attempt to obtain missing information. The firm's response was inadequate as a revised Complaint Handling Procedure was not provided. 2. **Failure to control device design (21 C.F.R. 820.30(a))**: The Design Control Procedure was not implemented. Design validation for the Triton Pump System did not include testing of production units under actual or simulated use (21 C.F.R. 820.30(g)). Design Input for the Triton Infusion Pump lacked inputs for administration sets (21 C.F.R. 820.30(c)). The Triton Infusion Pump Risk Analysis/Failure Modes and Criticality Analysis was incomplete, failing to identify hazards with administration