FDA WARNING_LETTER - Cane S.p.A. - February 19, 2015

On July 29, 2015, the FDA issued a Warning Letter to Cane S.p.A. following an inspection from February 16-19, 2015, at their Rivoli-Turino, Italy facility. The inspection revealed that the firm's infusion pumps and accessories, including the Crono S-PID-50 pump, are adulterated under 21 U.S.C. § 351(h) because their manufacturing methods, facilities, or controls do not conform to the Quality System (QS) regulation (21 CFR Part 820).

Key violations include: 1. **Failure to validate device design (21 CFR 820.30(g))**: No procedure for code testing software for infusion pumps, undocumented test results, and unaddressed software defects, leading to malfunctions and failed firmware updates. The firm's response was inadequate as no procedure was provided, and no retrospective review was discussed. 2. **Failure to establish and maintain complaint procedures (21 CFR 820.198(a))**: 26 out of 30 reviewed repair records for PID pumps in 2013-2014, including piston operation errors and alarm failures, were confirmed complaints with no investigation or MDR reporting evaluation. Additionally, 32 infusion pump complaints in 2013-201