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# Tom’s of Maine CGMP Issues
- URL: https://www.fdaweb.com/toms-of-maine-cgmp-issues/
- Published: 2024-11-19T12:00:00.000Z
- Updated: 2026-09-14T14:47:28.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5158209

A 5/7-5/22 FDA inspection at the Colgate-Palmolive/Tom’s of Maine over-the-counter drug manufacturing facility in Sanford, ME, found significant violations of current good manufacturing practice (CGMP) regulations for finished drugs. An 11/5 [Warning Letter](https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/colgate-palmolivetoms-maine-inc-687043-11052024?ref=fdaweb.com) says specific violations were:

- failure to follow appropriate written procedures, designed to prevent objectionable microorganisms in drug products not required to be sterile;
- failure to maintain buildings used in the manufacture, processing, packing, or holding of drug products in a good state of repair; and
- failure to establish and follow adequate written procedures describing the handling of all written and oral complaints regarding a drug product, including provisions for review by the quality control unit of any complaint involving the possible failure of a drug product to meet any of its specifications, and for such drug products, a determination of the need for an investigation.

FDA recommends that the company engage a qualified consultant to assist it in meeting CGMP requirements. Tom’s was told to respond with a list of specific actions it has taken to address violations and prevent their recurrence, with a schedule for completing the corrections.