FDA Hits Ecolab for Sterility Issues in Pharmaceutical Grade Purified Water

February 20, 2019

The FDA cited Ecolab over quality failures for USP purified water at its Huntington, Ind. facility.

In a Nov. 5-9, 2018 inspection, the FDA found the facility lacked adequate procedures to prevent potentially harmful microorganisms in the purified water it used in drug product formulations.

The facility lacked a written procedure for performing a repeat speciation required by its SOP for microbiological analysis of process water, and the method it was using at the time — choosing a second colony from the initial water sample plate — was determined to be scientifically unsound. “There is no assurance that the second colony is the same organism as what was originally identified,” the Form 483 noted.

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