FDA WARNING_LETTER - WalkMed Infusion, LLC - June 11, 2015

On May 18-June 11, 2015, an FDA inspection of WalkMed Infusion, LLC, identified significant violations of Quality System (QS) regulation for medical devices, specifically Triton and Triton FP volumetric infusion pumps and administration sets. The devices were deemed adulterated under 21 U.S.C. § 351(h) due to non-conformity with CGMP requirements.

Key violations include: 1. **Inadequate Complaint Investigations (21 CFR 820.198(c)):** Failure to adequately investigate complaints, including those related to air infusion/air-in-line detection system failures and patient infusion reactions. The firm's responses were insufficient, lacking justification for unreviewed complaints, inadequate CARs, unprovided CAPA documents, and failure to address supplier non-conformances or conduct retrospective assessments. 2. **Failed CAPA Procedures (21 CFR 820.100(a)(1)):** Failure to implement CAPA procedures to analyze and identify causes of nonconforming products, such as excess flow rate/over-infusions. The statistical methodology used was deemed inappropriate. Required CAPA documents were not provided. 3. **Inadequate Nonconforming Product Control (21 CFR 820.90(a)):** Continued distribution of Triton FP pumps with potential defects due to unaddressed root causes and failure to