FDA WARNING_LETTER - Tom's of Maine, Inc. - May 22, 2024

The FDA inspected Tom's of Maine, Inc. (FEI 1218077) in Sanford, ME, from May 7-22, 2024, identifying significant Current Good Manufacturing Practice (CGMP) violations, rendering their drug products adulterated under 21 U.S.C. 351(a)(2)(B).

Key violations include: 1. **Failure to prevent objectionable microorganisms (21 CFR 211.113(a)):** * *Pseudomonas aeruginosa* was found in water samples used for manufacturing and equipment rinsing, with no investigation into product impact or water system performance. * *Ralstonia insidiosa* (TNTC) was recovered from water points of use, with inadequate investigations and product release based on retesting. * *Paracoccus yeei* was recovered in finished product (Wicked Cool! Anticavity Toothpaste, batch 3025UST11B), with an unsubstantiated conclusion of sample contamination and release based on retest. * The firm's (b)(4) water system was inadequately qualified; IQ/OQ data was not evaluated timely, and PQ lacked TOC, conductivity, and gram-negative microorganism analysis, despite product specifications requiring their absence. The firm's response was deemed inadequate, lacking supporting evidence and a comprehensive