FDA WARNING_LETTER - Z-Medica, LLC - November 03, 2009

On December 3, 2009, the FDA issued a Warning Letter to Z-Medica Corporation following an inspection from October 26-28 and November 3, 2009. The inspection revealed that Z-Medica's medical devices, including QuikClot Combat Gauze, were adulterated under 21 U.S.C. 351(h) due to non-conformity with Current Good Manufacturing Practice (CGMP) requirements of the Quality System (QS) regulation (21 C.F.R. Part 820).

Violations included: 1. **Failure to fully validate and approve according to established procedures (21 CFR 820.75(a))**: The sterilization validation procedure for QuikClot Combat Gauze did not meet ISO 11137-2:2006 Part 2 requirements for using multiple product lots, and dosimeters/biological indicators were not placed in routine production runs for gamma sterilization. Z-Medica's proposed re-validation with three lots by December 31, 2009, was acknowledged, but data was requested. 2. **Failure to establish and maintain procedures for monitoring and control of process parameters (21 CFR 820.75(b))**: The sealing machine process validation lacked documentation for periodic burst testing. A change from burst to