Cush finds seven-year-old sterilization problems won't be solved overnight. (Medical Devices).(Cush Industries Inc.)

Inspection Monitor | September 1, 2002 | Copyright

Cush Industries, Inc., Piney Flats, TN, New Orleans District

Class I and II medical device manufacturer Cush Industries is still working to bring its Piney Flats, TN, facility into compliance, according to an Aug. 27 interview with COO Shirley Smith.

While handwritten annotations to the company's 483 stated promised corrections of "within 6 weeks" for non-sterilization deficiencies and "within 3 months" for EtO sterilization items, Smith said achieving compliance has taken longer than the firm originally anticipated. Even a March 1 letter to the agency had ...

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