FDAnews Device Daily Bulletin

Another Warning Letter Issued to Steris

Nov. 14, 2008
Devicemaker Steris did not establish adequate product control procedures after several loads of incorrect device sterilizers were shipped to customers, landing the company its third warning letter in a little more than a year. Two ethylene oxide loads that did not meet the required steam duration times and temperatures were shipped to customers with deviations, the FDA says in the letter. Steris said it opened a corrective and preventive action (CAPA) to address the incorrectly processed loads. But that response didn’t satisfy the agency because products processed before the CAPA was implemented were not addressed, the letter says.
The GMP Letter