I-Flow Corporation – FDA Warning Letter

This FDA Warning Letter, issued to I-Flow Corporation on December 22, 2008, details significant Quality System (QS) regulation violations observed during an inspection from March 11 to May 12, 2008, regarding their elastomeric infusion pumps. The devices are deemed adulterated under 21 U.S.C. 351(h) due to non-conformity with CGMP requirements (21 C.F.R. Part 820).

Key violations include: 1. **Failure to verify device design (21 C.F.R. 820.30(f)):** Devices were not tested for labeled design specifications, and design inputs were not met in design verifications, with unresolved performance discrepancies. 2. **Failure to control design changes (21 C.F.R. 820.30(i)):** Design changes, including those from CAPAs for stuck bolus buttons and incomplete welds, were not adequately validated or verified, with some changes failing tests. 3. **Inadequate process validation (21 C.F.R. 820.75(a)):** Pre- and post-sterilization flow rate specifications lacked proper validation and correlation. 4. **Insufficient documentation of validated processes (21 C.F.R. 820.75(