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

Source: https://www.keypedia.com/records/warning_letter/toms-of-maine-inc/0c170f03-9134-4cdd-8e1e-59cb82f62735

> FDA WARNING_LETTER for Tom's of Maine, Inc. on May 22, 2024. Product: Drugs. Access full analysis and detailed observations.

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## Details

- Record Type: WARNING_LETTER
- Company Name: Tom's of Maine, Inc.
- Inspection Date: 2024-05-22
- Product Type: Drugs
- Office Name: Center for Drug Evaluation and Research
- Summary: 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

## Related Documents

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## Related Officers

- [Director](https://www.keypedia.com/people/francis-godwin/1556d203-d47c-4744-af37-2591a163149e)

Company: https://www.keypedia.com/companies/toms-of-maine-inc/4b3b44e0-d661-40b1-b271-61a8f81eccf7

Office: https://www.keypedia.com/offices/center-for-drug-evaluation-and-research/cd980d74-1cbf-4226-ba9a-9045324c236c