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

An FDA inspection of Ecolab, Inc.'s manufacturing facility in Huntington, Indiana, conducted from November 5-9, 2018, identified significant deviations from established manufacturing practice standards. The observations primarily concerned the company's quality and laboratory systems. Key issues included a failure to thoroughly investigate unexplained discrepancies and out-of-specification events, such as repeated instances of *Pseudomonas aeruginosa* or *Burkholderia cepacia* contamination in USP Purified Water samples from 2017-2018, which affected numerous distributed drug product lots. Additionally, the firm did not adequately investigate out-of-specification stability chamber conditions or several internal non-conformances. The inspection also highlighted inadequate procedures for preventing objectionable microorganisms in non-sterile drug products, specifically lacking scientifically sound methods for microbial identification in purified water and proper controls for laboratory growth media. Furthermore, a critical absence of independent review was noted in laboratory records, with raw material testing, product release, and purified water sample data not undergoing verification by a second qualified individual. Ecolab, Inc. is required to implement comprehensive corrective actions and provide a detailed response to the FDA to address these findings and ensure compliance with manufacturing regulations.