# FDA 483 - Tom's of Maine, Inc. - May 22, 2024

Source: https://www.keypedia.com/records/483/toms-of-maine-inc/f02c9c11-b71b-43d8-a6f6-4d4da6b2751d

> FDA 483 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: 483
- Company Name: Tom's of Maine, Inc.
- Inspection Date: 2024-05-22
- Product Type: drugs
- Office Name: New England District Office
- Summary: Tom's of Maine, Inc., an OTC drug manufacturer in Sanford, ME, was cited for significant deficiencies during an FDA inspection. The firm failed to thoroughly investigate microbial contamination in its water system and numerous customer complaints, and lacked adequate procedures to prevent objectionable microorganisms. Additionally, the facility exhibited poor maintenance, and the quality control unit demonstrated inadequate oversight of manufacturing systems and document control.

## Related Documents

- [WARNING_LETTER - 2024-05-22](https://www.keypedia.com/records/warning_letter/toms-of-maine-inc/0c170f03-9134-4cdd-8e1e-59cb82f62735)

## Related Officers

- [Deputy Director](https://www.keypedia.com/people/lori-m-newman/a0e448e4-11ba-4095-b879-feabb8750b3f)

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

Office: https://www.keypedia.com/offices/new-england-district-office/aa458072-2f1d-4231-89f5-21ba7a3b7144