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For 30 years, devicemakers have relied on The GMP Letter for the latest on the FDA's interpretation and enforcement of cGMPs and Quality Systems Regulation, information readers need to stay in compliance. Each monthly issue brings its readers updates on the FDA’s approach to facility inspections, changes to the EU’s unannounced inspections and the latest on joint inspections in these and other jurisdictions.

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The GMP Letter

The GMP Letter

Falls Church, VA (PRWEB) August 28, 2014

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Steris Corporation was warned by the FDA for several violations related to employee data manipulation and falsification.

The company’s Libertyville, Ill., facility opened an investigation in July 2013 to look into instances where product was overdosed but later made to appear within specification.

However, the inspection fell short because it did not include a review of all potentially affected products, according to the May 22 warning letter posted recently online.

Steris also initiated local nonconformances for three instances of data manipulation at three separate facilities, but did not bump the issue to a corporate CAPA before the FDA’s inspection, the letter says. This would have allowed the company to address the issue across all STERIS Isomedix gamma irradiation facilities...

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For 30 years, devicemakers have relied on The GMP Letter for the latest on the FDA's interpretation and enforcement of cGMPs and Quality Systems Regulation, information readers need to stay in compliance.

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