Aurora Spine

Steris Isomedix Still on FDA Naughty Step June 9, 2014

Steris would have shifted uncomfortably in its chair as it read the FDA’s recent letter which chided it for the inadequacy of its response to earlier warnings.

Background

On May 22nd the U.S. FDA issued a warning letter to Steris Corporation, which can be found here. The letter details the agency’s response to Steris’ own addressing of problems raised during earlier audits performed since last October.

The nine points that have formed the basis of the correspondence form a pretty serious list, ranging from inadequate procedures for sharing non conformance information, investigating those non conformances, executive review of the quality system, organisational structure to implement it, control over processes, validation of software and inadequate review of corrective and preventive action measures.

The FDA doesn’t sound at all pleased with what the company has said in response to its earlier warnings, bandying around words like “inadequate” and “failure” on several points. Perhaps the most serious relate to actions going back as far as 2008 in which employees had been shown to manipulate or falsify data. On one point, relating to Steris’ Isomedix business, the FDA response states; “We have reviewed your responses and have determined that they are inadequate because the responses failed to identify actions to address the reasons why it took three discrete incidents of data manipulation/falsification and an FDA inspection to initiate a change in the quality system, including a shift in responsibilities to the Quality Unit to approve or reject processed medical devices.”

Scanning through all 9 points, one picks up the flavour that the FDA isn’t generally all that satisfied with how Steris has addressed the issues raised, which is actually a bit unfair, some of the matters requiring follow-up visits before they could be closed out. That said, the stern tone is unmistakeable, the letter’s closing paragraphs including; “You should take prompt action to correct the violations addressed in this letter. Failure to promptly correct these violations may result in regulatory action being initiated by the Food and Drug Administration without further notice. ”

All in all, it’s got to be a bit of an “ouch”moment to see this amount of dirty laundry being aired in public.

Source: FDA

 

 

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