Steris Isomedix Inc

Recipient: Steris Isomedix Inc
Product:sterilizes medical devices.
Date: 9/25/2008

We have reviewed your response dated July 16, 2008, and have concluded that it is inadequate because while you have opened a Correction and Preventative Action (CAPA) to address this issue, your corrective actions did not address any product that was processed prior to the initiation of this CAPA.

2. Failure to establish and maintain adequate procedures to identify all the actions needed to correct and prevent the recurrence of nonconforming product and other quality problems as required by 21 CFR 820.100(a)(3). For example, on 2/15/07, load R070215-07 was processed using revision 10 of the cycle; however, revision 9 was the currently approved version. Your firm was notified by the customer that the load was processed incorrectly. You subsequently opened a CAPA to address this issue and later identified the root cause of the problem as the [redacted] server migration of unapproved cycles into the [redacted] software. However, at the time, you did not initiate any preventative actions to ensure that this problem does not recur.

5. Failure to adequately validate computer software used as part of production, as required by 21 CFR 820.70(i). For example, your [redacted] software, used for the sterilization chambers, was not adequately validated in that unapproved ETO sterilization cycle revisions are migrated from the [redacted] server into the software and are not identified as unapproved cycles. The ETO chamber operators can access these unapproved cycles and run the non validated sterilization cycles without the customers consent.

FDA New England District Office

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