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Colgate-Palmolive/Tom's of Maine, Inc.'s drug manufacturing facility in Sanford, Maine was cited for significant Current Good Manufacturing Practice (CGMP) violations in the production of over-the-counter drug products, rendering them adulterated. The company failed to implement appropriate written procedures to prevent objectionable microorganisms in non-sterile drugs, with inspectors discovering Pseudomonas aeruginosa in multiple water samples used to manufacture Tom's Simply White Clean Mint Paste and for equipment cleaning between June 2021 and October 2022, yet the firm did not investigate these incidents to assess product impact or water system performance. Additionally, the facility repeatedly recovered "too numerous to count" levels of Ralstonia insidiosa at water points of use without adequate investigation protocols.