FDA WARNING_LETTER - MEDDEV USA, INC. - May 11, 2012

On October 9, 2012, the FDA issued a Warning Letter to MEDDEV USA, Inc. following an inspection from May 9-11, 2012, which found their Portal Vein Cannula devices adulterated and misbranded.

The inspection revealed numerous Quality System (QS) regulation violations (21 CFR Part 820). These included: * Failure to establish and maintain adequate procedures for design control (21 CFR 820.30(a)), design validation (21 CFR 820.30(g)), corrective and preventive action (21 CFR 820.100(a)), complaint handling (21 CFR 820.198(a)), and acceptance activities (21 CFR 820.80(a)). * Failure to maintain adequate Device Master Records (DMRs) (21 CFR 820.181) and Device History Records (DHRs) (21 CFR 820.184). * Failure to establish adequate purchasing control procedures (21 CFR 820.50) and quality policy/objectives (21 CFR 820.20(a)).

Additionally, the devices were misbranded due to: * Failure to develop and implement adequate Medical Device Reporting (MDR) procedures (21