FDA 483 - Ecolab, Inc. - November 09, 2018

An FDA inspection of Eco-Lab, Inc. in Huntington, IN, revealed significant quality system deficiencies. The firm failed to thoroughly investigate unexplained discrepancies, including microbial contamination in water used for drug products and out-of-specification stability chamber conditions. Additionally, the inspection cited a lack of established procedures for preventing objectionable microorganisms and inadequate second-person review of laboratory records.