Steris Facility Gets Warning for Sterilizing Procedures

Steris Isomedix Services has received a warning letter citing it for not establishing adequate procedures involving its relative humidity (Rh) monitors.

During an inspection of the company’s Grand Prairie, Texas, facility, FDA investigators found Steris had no procedures to address how many monitors are placed in a sterilization load and how it accepts or rejects Rh data recorded during routine sterilization cycles subject to parametric release.

Steris is under a consent decree to transition its customers from its System 1 sterilizer to other alternatives. The warning letter will have no impact on that consent decree, Steris spokesman Stephen Norton said.
The GMP Letter