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Inadequate Quality and Validation Procedures Draw WarningPosted on January 12, 2009 @ 10:12 amSterilization 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. To view the warning letter, visit http://www.fda.gov/foi/warning_letters/s7056c.htm. |
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