Industry News, Regulations

FDA Warning Letter Cites Significant CGMP Violations at Tom’s of Maine Factory

Bacteria and mold-like substances found in Maine oral care manufacturing factory.

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By: Christine Esposito

Editor-in-Chief

The US Food and Drug Administration (FDA) has sent a warning letter to Colgate-Palmolive CEO Nicole Wallace regarding an inspection at a Tom’s of Maine manufacturing facility in Sanford, ME that uncovered bacteria and powdery and mold-like substances. The inspection was conducted from May 7-22, 2024. The warning letter was dated Nov. 5, 2024. Among the issues cited by FDA was Pseudomonas aeruginosa recovered in multiple water samples from June 2021 to October 2022. The water was ...

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