Colgate-Palmolive/Tom's of Maine, Inc.

Warning LetterOpen

Mr. Noel Wallace Chief Executive Officer Colgate-Palmolive/Tom's of Maine, Inc. 300 Park Avenue New York , NY 10022 United States Noel_Wallace@colpal.comFEI 1218077Issued Nov 5, 2024Center for Drug Evaluation and Research (CDER)

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Source: FDA, published letter. FDA published this warning letter; View Letter opens FDA's copy. To check it, open FDA's record for this establishment, listed under FEI 1218077.

Violations4

Issue DateNov 5, 2024

Product TypeDrugs

StatusOpen

Letter Details

Firm: Colgate-Palmolive/Tom's of Maine, Inc.
Location: Mr. Noel Wallace Chief Executive Officer Colgate-Palmolive/Tom's of Maine, Inc. 300 Park Avenue New York , NY 10022 United States Noel_Wallace@colpal.com
FEI Number: 1218077
Country: United States
Issue Date: November 05, 2024
Issuing Office: Center for Drug Evaluation and Research (CDER)
Product Type: Drugs
Status: Open

Summary

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.

Colgate-Palmolive/Tom's of Maine, Inc. FDA Warning Letter, November 5, 2024