Inadequate Quality and Validation Procedures Draw Warning

Sterilization assurance company Steritec Products is pulling certain lots of one of its products, following a recent warning letter by the U.S. Food and Drug Administration. 

Customers complained when Steritec’s Flash Integrator didn’t change colors in a three-minute sterilization cycle, according to an October warning letter issued by the FDA. 

Those complaints prompted the withdrawal by the Castle Rock, Colo.-based company. 

The Steritec Integrator gives a visible confirmation of the attainment of sterilization conditions at the location within the sterilizer chamber.