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.