Cenorin, LLC – FDA Warning Letter, May 2, 2014
An FDA inspection from April 9 to May 2, 2014, at 6324 South 199th Place, Suite 107, Kent, Washington, revealed that the firm's Medical Device Cleaning and HLD Washer/Pasteurizer System Model 610 device is misbranded and adulterated.
The device is misbranded under section 502(t)(2) of the Act [21 U.S.C. § 352(t)(2)] due to failure to report corrections or removals as required by 21 CFR 806.10. Specifically, the firm failed to notify FDA of customer notifications issued on January 24, 2013, December 23, 2013, and April 24, 2014, regarding issues with temperature control, false temperature sensor readings, failure to pasteurize, and cleaning fluid pump failure. These actions were determined to meet the definition of a Class II Recall and should have been reported. The firm's May 21, 2014, response to the FDA 483 did not include actions to prevent recurrence.
The device is also adulterated under section 501(f)(1)(B) of the Act [21 U.S.C. § 351(f)(1)(B)] because
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- Seattle District Office
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ID · 0e5b0cf6-6784-4a53-b9e3-732792bdb3f2
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